Identity
- Trade Name
- OrthoStore - REPLICA, NO FLAVOR ALGINATE FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- REPLICA, NO FLAVOR ALGINATE FDA UDI
- Model / Reference
- 625-963 FDA UDI
- Description
- REPLICA, NO FLAVOR ALGINATE FDA UDI
Identifiers
- Catalog Number
- 625-963 FDA UDI
- Primary DI / UDI-DI
- 00843471100103 FDA UDI
- 510(k) Number
- K925746 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Alginate dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
No
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
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: Alginate dental impression material
OrthoStore - REPLICA, NO FLAVOR ALGINATE by Young Innovations Holdings Llc — Class II — 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
Cleared under the same submission
K925746 also covers:
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
- Young Innovations Holdings Llc
Sources (1)
- FDA UDI 500c22d9-9c1d-40f6-9b57-a112ec315d3a 35 fields · synced Jun 7, 2026