Identity
- Trade Name
- TISSUE GUARD FDA UDI
- Generic Name
- Orthodontic inter-arch elastic band FDA UDI
- Device Name
- .027 TISSUE GUARD CLEAR - 10' SPOOL FDA UDI
- Model / Reference
- 340-305 FDA UDI
- Description
- .027 TISSUE GUARD CLEAR - 10' SPOOL FDA UDI
Identifiers
- Catalog Number
- 340-305 FDA UDI
- Primary DI / UDI-DI
- D90934030501 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic inter-arch elastic band FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic inter-arch elastic band
Tissue Guard by Ortho Arch Company Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic inter-arch elastic band.
- Relastics — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- EXTREME SPORTS — G&H Wire Company, Inc. · Class I
- Ortho Pro — Ortho Pro Dent LLC · Class I
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY · Class I
- KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTIC — ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- Young Specialties — Young Innovations, 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 55c7e476-f4e2-477c-a519-3f20a687a988 34 fields · synced Jun 1, 2026