Chrysalis Intelligence · Product Codes · OAT

OAT · Implant, Endosseous, Orthodontic

Dental · 14 clearances · 14 unique sponsors

Device class
Class II
Regulation 872.3640
Total clearances
14
2020-01-17 → 2026-05-19
Last 12 months
1
Unique sponsors
14
Definition

What is Implant, Endosseous, Orthodontic

It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Medical specialty
Dental
Review panel
DE
Regulation number
872.3640
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
Osteonic Co., Ltd. 1 0 2021-10-15
Gni Co., Ltd. 1 0 2020-08-28
Bernhard Förster GmbH (Bernhard Foerster Ltd.) 1 1 2026-05-19
Mk Meditech, Inc. 1 0 2021-12-19
Ze Fang Technology Co., Ltd. 1 0 2022-10-07
Biomaterials Korea, Inc. 1 0 2023-08-21
Proimtech Saglik Urunleri Anonim Sirketi 1 0 2024-09-04
Techwin Co., Ltd. 1 0 2024-02-08
Bomei Co, Ltd. 1 0 2021-01-08
Blue Sky Bio, LLC 1 0 2020-12-17
Syntec Scientific Corporation 1 0 2021-09-17
Biocetec Co., Ltd. 1 0 2020-01-17
Leone S.P.A. 1 0 2025-06-19
Craniofacial Technologies, Inc. 1 0 2022-04-28
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
20999 CPT Medium Unlisted orthopedic/dental surgical procedure for temporary implant placement
21999 CPT Medium Unlisted dentomaxillofacial procedure code for orthodontic implant
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-05-19 K260268 Bernhard Förster GmbH (Bernhard Foerster Ltd.) OrthoEasy Pal; OrthoEasy Pal Long Neck
2025-06-19 K242944 Leone S.P.A. Leone Orthodontic Implant TAD (Temporary Anchorage Device)
2024-09-04 K231502 Proimtech Saglik Urunleri Anonim Sirketi Mini Screws
2024-02-08 K231913 Techwin Co., Ltd. T-FIT
2023-08-21 K222245 Biomaterials Korea, Inc. ACR Screw System
2022-10-07 K202163 Ze Fang Technology Co., Ltd. Mico One Orthodontic Screw
2022-04-28 K202691 Craniofacial Technologies, Inc. Ortholock Anchorage Devices
2021-12-19 K210559 Mk Meditech, Inc. ATOZ Mini-Screw
2021-10-15 K211992 Osteonic Co., Ltd. Ortho MI System
2021-09-17 K202790 Syntec Scientific Corporation Syntec Orthodontic Mini Screw Extended System
2021-01-08 K202278 Bomei Co, Ltd. OBS Anchorage Screw, Biokey Anchorage Screw
2020-12-17 K201919 Blue Sky Bio, LLC Blue Sky Bio TAD
2020-08-28 K191041 Gni Co., Ltd. Orthodontic Fixation Screw [Smart Anchor Miniscrew]
2020-01-17 K190871 Biocetec Co., Ltd. Bio-TackS Orthodontic Mini Implant