NHA · Abutment, Implant, Dental, Endosseous

Device class

Class II

Regulation 872.3630

Total clearances

256

2020-01-02 → 2026-09-23

Last 12 months

Unique sponsors

Definition

What is Abutment, Implant, Dental, Endosseous

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.3630

Implant

Life-sustain / support

GMP exempt

Third-party review

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
Arum Dentistry Co., Ltd.	6	0	2024-11-25
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
Medentika GmbH	5	1	2025-12-23
Prismatik Dentalcraft, Inc.	5	1	2025-11-18
Hiossen, Inc.	5	2	2026-05-14
JJGC Indústria e Comércio de Materiais Dentários S.A.	5	3	2026-07-01
BioHorizons Implant Systems, Inc.	4	1	2026-06-26
Cowellmedi Co., Ltd.	4	0	2025-09-16
Ossvis Co., Ltd.	4	0	2024-12-05
Osstem Implant Co., Ltd.	4	1	2026-03-04
Innobiosurg Co., Ltd.	4	0	2021-08-25
Open Implants, LLC	4	0	2025-06-26
Imagine Milling Technologies, LLC	3	1	2026-06-27
Simda Co., Ltd.	3	1	2025-12-18
Dio Corporation	3	0	2023-08-18

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.

Code	Type	Description	Confidence	Rationale
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

Date	K-number	Sponsor	Device
2026-09-23	K262207	Unidental Co., Ltd.	Cemented Plus Abutment
2026-09-21	K260940	ZimVie US Corp, LLC	BellaTek Bars
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