Chrysalis Intelligence · Product Codes · NHA

NHA · Abutment, Implant, Dental, Endosseous

Dental · 254 clearances · 85 unique sponsors

Device class
Class II
Regulation 872.3630
Total clearances
254
2020-01-02 → 2026-08-06
Last 12 months
36
Unique sponsors
85
Definition

What is Abutment, Implant, Dental, Endosseous

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Medical specialty
Dental
Review panel
DE
Regulation number
872.3630
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Terrats Medical SL 18 4 2026-06-09
Institut Straumann AG 15 2 2026-05-07
Dentsply Sirona 15 3 2025-12-09
Dentis Co., Ltd. 12 0 2024-07-25
Elos Medtech Pinol A/S 11 2 2026-05-20
Truabutment, Inc. 9 0 2024-10-09
Megagen Implant Co., Ltd. 7 0 2025-01-13
Zest Anchors, LLC 7 2 2026-04-09
Implant Protesis Dental 2004, S.L. 6 1 2026-01-22
Nobel Biocare AB 6 1 2026-08-06
Talladium España, SL 6 1 2026-01-29
Arum Dentistry Co., Ltd. 6 0 2024-11-25
Hiossen, Inc. 5 2 2026-05-14
Medentika GmbH 5 1 2025-12-23
Prismatik Dentalcraft, Inc. 5 1 2025-11-18
JJGC Indústria e Comércio de Materiais Dentários S.A. 5 3 2026-07-01
Cowellmedi Co., Ltd. 4 1 2025-09-16
BioHorizons Implant Systems, Inc. 4 1 2026-06-26
Open Implants, LLC 4 0 2025-06-26
Innobiosurg Co., Ltd. 4 0 2021-08-25
Osstem Implant Co., Ltd. 4 1 2026-03-04
Ossvis Co., Ltd. 4 0 2024-12-05
Southern Implants (Pty), Ltd. 3 0 2023-08-01
B.T.I. Biotechnology Institute, Sl. 3 0 2023-12-08
Jjgc Industria E Comercio DE Materiais Dentarios S.A. 3 0 2023-07-14
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
D6064 CPT High Implant abutment, porcelain/ceramic (CDT code, used in dental billing)
99070 CPT Medium Supplies and materials for dental implant abutment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-06 K253999 Nobel Biocare AB 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
2026-07-01 K261147 JJGC Indústria e Comércio de Materiais Dentários S.A. Neodent Implant System - NeoConvert Fit
2026-06-27 K261122 Imagine Milling Technologies, LLC MIST IC
2026-06-26 K260061 BioHorizons Implant Systems, Inc. BioHorizons CEREC Compatible Ti-Bases
2026-06-15 K253922 JJGC Indústria e Comércio de Materiais Dentários S.A. Neodent Scannable Healing Abutment
2026-06-11 K254145 Smart Denture Conversions, LLC Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
2026-06-09 K260564 Terrats Medical SL DESS Dental Smart Solutions
2026-06-03 K252904 Sic Invent AG SIC Abutments including CAD/CAM Solutions
2026-05-20 K253774 Elos Medtech Pinol A/S Elos Accurate® Denture Fixation System
2026-05-14 K253372 Hiossen, Inc. ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
2026-05-07 K260460 Institut Straumann AG Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
2026-04-16 K253804 Terrats Medical SL DESS Dental Smart Solutions
2026-04-09 K260555 Zest Anchors, LLC LOCATOR® Angled Abutment
2026-03-04 K251434 Osstem Implant Co., Ltd. Healing Abutment System
2026-02-10 K251515 CreoDent Hudson Valley Solidex® Ti-Links and Screws
2026-01-29 K251427 Hiossen, Inc. EK MULTI ANGLED 30 ABUTMENT
2026-01-29 K243732 Talladium España, SL Multi-Unit DAS System
2026-01-22 K253315 Institut Straumann AG Straumann Variobase Abutments XC for Bridge/Bar
2026-01-22 K253253 Implant Protesis Dental 2004, S.L. IPDmilled Blanks
2026-01-07 K252727 JJGC Indústria e Comércio de Materiais Dentários S.A. Neodent InLab Validated Workflow
2025-12-23 K253341 Medentika GmbH Custom Abutments AS
2025-12-23 K253312 Orangecad Med GmbH OrangeCAD Med Abutments
2025-12-18 K252320 Simda Co., Ltd. SIMDA Abutments
2025-12-09 K252343 Dentsply Sirona Atlantis® Abutments in Titanium
2025-11-26 K252248 Dentsply Sirona CEREC Tessera Abutment System