Identity
- Trade Name
- Impressa/Sure FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- SUPPLIES-IMPRESSA/SURE MIXING TIPS PK/50 FDA UDI
- Model / Reference
- 861-139 FDA UDI
- Description
- SUPPLIES-IMPRESSA/SURE MIXING TIPS PK/50 FDA UDI
Identifiers
- Catalog Number
- 861-139 FDA UDI
- Primary DI / UDI-DI
- 00190746035067 FDA UDI
- FDA Product Code
- EID FDA UDI
- GMDN Term
- Alginate dental impression material 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
Yes
FDA UDI
Category: Alginate dental impression material
Impressa/Sure by American Orthodontics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alginate dental impression material.
- Bosworth Supergel — Harry J. Bosworth Co. · Class II
- Jeltrate® Plus Antimicrobial Dustless Alginate Impression Material — Dentsply International · Class II
- Orthoquest — Young Innovations, Inc. · Class II
- MDC Dental — MDC DENTAL · Class II
- KROMOPAN — Lascod Spa · Class II
- Allgilloid Plus™ Chromatic Mint Alginate — ORTHO SPECIALTIES · Class II
- Orthoquest — Young Innovations, Inc. · Class II
- Powder scoop + Water measure Neutral — Cavex Holland B.V. · 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
- American Orthodontics
Sources (1)
- FDA UDI b3cc2571-9624-49ad-a846-4275ea601b99 35 fields · synced Jun 9, 2026