Chrysalis Intelligence · Sponsors · Nobel Biocare AB

Nobel Biocare AB

Goteborg, SE · 16 510(k) clearances · 2 recalls

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Total clearances
16
2020-03-30 → 2026-09-08
Last 12 months
3
Product codes
5
Most recent
2026-09-08
Name variants in FDA filings: Nobel Biocare AB / Nobel Biocare AG
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NHA Abutment, Implant, Dental, Endosseous Class II Dental 6 2026-08-06
DZE Implant, Endosseous, Root-Form Class II Dental 4 2026-02-18
LLZ System, Image Processing, Radiological Class II Radiology 4 2023-12-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories Class II General Hospital 1 2026-09-08
MYN Analyzer, Medical Image Class II Radiology 1 2023-03-28
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
2
Most recent
2025-01-10
DateSeverityStatusRecall # ProductCodeReason
2025-01-10 Class II Ongoing Z-1101-2025 . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP… — Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the steril…
2022-07-25 Class II Ongoing Z-1565-2022 Nobel Biocare N1 TiUltra TCC NP 3.5x13mm — Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Filings

All 510(k) clearances (16)

Date K-number Device Code Class Specialty
2026-09-08 K253988 LiteSet Trays KCT Class II General Hospital
2026-08-06 K253999 Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw NHA Class II Dental
2026-02-18 K252197 Nobel Biocare S Series Implants DZE Class II Dental
2025-08-25 K243834 NobelZygoma TiUltra Implant system DZE Class II Dental
2025-01-03 K240346 NobelProcera Zirconia Implant Bridge NHA Class II Dental
2024-01-24 K233208 NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium NHA Class II Dental
2023-12-08 K231898 DTX Studio Clinic (4.0) LLZ Class II Radiology
2023-04-28 K223677 Titanium Abutment Blank Nobel Biocare N1 TCC NHA Class II Dental
2023-03-28 K221921 DTX Studio Clinic 3.0 MYN Class II Radiology
2022-03-25 K213562 DTX Studio Clinic 3.0 LLZ Class II Radiology
2021-09-24 K212125 Nobel Biocare Dental Implant Systems Portfolio - MR Conditional DZE Class II Dental
2020-12-03 K202452 NobelProcera Zirconia Implant Bridge NHA Class II Dental
2020-11-20 K203156 DTX Studio Clinic LLZ Class II Radiology
2020-11-16 K202344 TiUltra Implants and Xeal Abutments DZE Class II Dental
2020-10-08 K200810 IPS CaseDesigner LLZ Class II Radiology
2020-03-30 K200040 Universal Base Conical Connection (CC) NHA Class II Dental
Data source: openFDA · Generated 2026-10-04 10:31 · Last ingest 2026-10-04T14:31:22.982976 · Pipeline: Chrysalis Intelligence