Chrysalis Intelligence · Sponsors · Biomet 3i, LLC

Biomet 3i, LLC

Palm Beach Gardens, FL, US · 6 510(k) clearances · 30 recalls

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Total clearances
6
2021-12-21 → 2025-06-27
Last 12 months
0
Product codes
2
Most recent
2025-06-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DZE Implant, Endosseous, Root-Form Class II Dental 4 2025-06-27
NHA Abutment, Implant, Dental, Endosseous Class II Dental 2 2024-07-15
Safety

Recalls (30)

Class I (serious)
0
Risk of injury / death
Total recalls
30
Currently ongoing
0
Most recent
2020-08-31
DateSeverityStatusRecall # ProductCodeReason
2020-08-31 Class II Terminated Z-0079-2021 CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6 — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-08-31 Class II Terminated Z-0078-2021 CERTAIN BELLATEK TITANIUM ABUTMENT 5.0MM Reference Number: IEDAT5 — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-08-31 Class II Terminated Z-0077-2021 CERTAIN BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: IEDAT4 — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-08-31 Class II Terminated Z-0076-2021 CERTAIN BELLATEK TIN ABUTMENT 5.0MM Reference Number: IEDAN5 — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-08-31 Class II Terminated Z-0075-2021 CERTAIN BELLATEK TIN ABUTMENT 4.1MM Reference Number: IEDAN4 — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-08-31 Class II Terminated Z-0074-2021 BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4 — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-08-31 Class II Terminated Z-0073-2021 BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ — Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may ca…
2020-01-10 Class II Terminated Z-1388-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1387-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1386-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1385-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1384-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1383-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1382-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1381-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1380-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1379-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA464 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1378-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1377-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1376-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1375-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1374-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1373-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1372-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1371-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1370-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1369-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1368-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1367-2020 CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
2020-01-10 Class II Terminated Z-1366-2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H) Reference Number: IEHA343 — Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin cont…
Filings

All 510(k) clearances (6)

Date K-number Device Code Class Specialty
2025-06-27 K251660 T3 Pro Implants– ZimVie Packaging System DZE Class II Dental
2024-10-23 K241753 Immediate Molar Implants DZE Class II Dental
2024-07-15 K241032 BellaTek Bars NHA Class II Dental
2022-09-14 K220978 TSX Implants DZE Class II Dental
2022-03-28 K213672 T3 Pro Implants DZE Class II Dental
2021-12-21 K212730 BellaTek Encode Emergence Healing Abutments NHA Class II Dental
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence