Chrysalis Intelligence · Product Codes · NJM

NJM · Unclassified

10 clearances · 8 unique sponsors

Device class
Regulation —
Total clearances
10
2020-02-21 → 2023-09-14
Last 12 months
0
Unique sponsors
8
Medical specialty
Review panel
Regulation number
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
Lightforce Orthodontics 3 0 2023-09-14
Gni Co., Ltd. 1 0 2021-03-12
Orthometric - Industria E Comercio DE Produtos Medicos 1 0 2023-05-04
Rayence Co., Ltd. 1 0 2022-05-06
Luce Castle Co., Ltd. 1 0 2020-10-09
Biocetec Co., Ltd. 1 0 2023-06-06
Dyna Flex 1 0 2023-06-05
American Orthodontics 1 0 2023-07-07
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)