Identity
- Trade Name
- COMPOSITE DIRECT BOND FDA UDI
- Generic Name
- Orthodontic aligner auxiliary attachment kit FDA UDI
- Device Name
- COMPOSITE DIRECT BOND BUTTON (10) FDA UDI
- Model / Reference
- 270-204 FDA UDI
- Description
- COMPOSITE DIRECT BOND BUTTON (10) FDA UDI
Identifiers
- Catalog Number
- 270-204 FDA UDI
- Primary DI / UDI-DI
- D90927020412 FDA UDI
- FDA Product Code
- ECQ FDA UDI
- GMDN Term
- Orthodontic aligner auxiliary attachment kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic aligner auxiliary attachment kit
Composite Direct Bond by Ortho Arch Company Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic aligner auxiliary attachment kit.
- C&C — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- 3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
- C&C — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- 3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
- Stick and Place — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- Morelli — Dental Morelli Ltda · Class I
- 3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
- Invisalign Pre-Formed Attachment System — Align Technology, Inc. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortho Arch Company Inc
Sources (1)
- FDA UDI fbbd7dab-6122-46b8-920e-350bd0580a06 34 fields · synced May 31, 2026