Identity
- Trade Name
- Vatech Clismile FDA UDI
- Generic Name
- Orthodontic bracket, ceramic FDA UDI
- Device Name
- This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material. FDA UDI
- Model / Reference
- 01-1253 FDA UDI
- Description
- This product is an orthodontic bracket and is used with orthodontic wire materials and other orthodontic products to treat malocclusion of the upper and lower teeth. It is used to correct teeth by transmitting physical force to each tooth and is a self-ligation bracket using a ceramic body and a metal cap made of a metal material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018601129 FDA UDI
- 510(k) Number
- K220689 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Orthodontic bracket, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic bracket, ceramic
Vatech Clismile by Rayence Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, ceramic.
- NeoCrystal Plus — Ortho Organizers, Inc. · Class II
- Ceramic/Metal Combination Kits — TP ORTHODONTICS, INC. · Class II
- TipEdge PLUS Ceramic Readi-Base Bracket — TP ORTHODONTICS, INC. · Class II
- Experience — GC Orthodontics America Inc. · Class II
- Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- APC™ II Clarity™ ADVANCED — 3M UNITEK CORPORATION · Class II
- EXPERIENCE® — GC Orthodontics America Inc. · Class II
- APC™ PLUS Clarity™ SL — 3M UNITEK CORPORATION · Class II
Cleared under the same submission
K220689 also covers:
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
- Vatech Clismile — Rayence Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rayence Co., Ltd.
Sources (1)
- FDA UDI 7cdb4c21-1924-4e19-883b-3ef48c74d46f 34 fields · synced Jun 8, 2026