Chrysalis Intelligence · Product Codes · NJM

NJM · Bracket, Ceramic, Orthodontic

Dental · 10 clearances · 8 unique sponsors

Device class
Class II
Regulation 872.5470
Total clearances
10
2020-02-21 → 2023-09-14
Last 12 months
0
Unique sponsors
8
Definition

What is Bracket, Ceramic, Orthodontic

An orthodontic ceramic bracket is a device composed of ceramic, which is intended to be bonded to a tooth, upon which an orthodontic wire is used to move the tooth to a new position.
Medical specialty
Dental
Review panel
DE
Regulation number
872.5470
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Lightforce Orthodontics 3 0 2023-09-14
Biocetec Co., Ltd. 1 0 2023-06-06
American Orthodontics 1 0 2023-07-07
Dyna Flex 1 0 2023-06-05
Luce Castle Co., Ltd. 1 0 2020-10-09
Orthometric - Industria E Comercio DE Produtos Medicos 1 0 2023-05-04
Rayence Co., Ltd. 1 0 2022-05-06
Gni Co., Ltd. 1 0 2021-03-12
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
D8010 CPT — High Orthodontic bracket, ceramic (CDT code used in dental billing)
99070 CPT — Medium Supplies for orthodontic materials
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-09-14 K232827 Lightforce Orthodontics LightForce Orthodontic System
2023-07-07 K232011 American Orthodontics Cleo
2023-06-06 K231635 Biocetec Co., Ltd. A-Line Advanced
2023-06-05 K230225 Dyna Flex DynaFlex Clear Brackets & Buttons
2023-05-04 K222847 Orthometric - Industria E Comercio DE Produtos Medicos Ceramic Brackets Orthometric
2022-09-14 K222764 Lightforce Orthodontics LightForce Orthodontic System
2022-05-06 K220689 Rayence Co., Ltd. Vatech Clismile
2021-03-12 K201410 Gni Co., Ltd. VENUS Bracket, ROSE Bracket
2020-10-09 K201038 Luce Castle Co., Ltd. Luce Ceramic Bracket
2020-02-21 K200148 Lightforce Orthodontics LightForce Orthodontic System (LFO System)