Identity
- Trade Name
- ORTHO ARCH FDA UDI
- Generic Name
- Dental cheek retractor, professional, reusable FDA UDI
- Device Name
- COTTON MOUTH BITE BLOCK FDA UDI
- Model / Reference
- 900-201 FDA UDI
- Description
- COTTON MOUTH BITE BLOCK FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9099002011 FDA UDI
- FDA Product Code
- DYN FDA UDI
- GMDN Term
- Dental cheek retractor, professional, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Dental cheek retractor, professional, reusable
Ortho Arch by Ortho Arch Company Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cheek retractor, professional, reusable.
- Power Dental USA — Power Dental USA, Inc. · Class I
- RETRACTOR MOZSARY — W.H. Holden, Inc. · Class I
- RETRACTOR APFEL — W.H. Holden, Inc. · Class I
- STERLING — BENCO DENTAL SUPPLY CO. · Class I
- GoldenDent — GoldenDent · Class I
- Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
- Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
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 063064e5-a624-402b-9452-e08bcd659ad4 33 fields · synced Jun 1, 2026