Identity
- Trade Name
- iSmile FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- iSmile Alginate Dustless Fast Set Impression Material Mint (1lb) FDA UDI
- Model / Reference
- 400012 FDA UDI
- Description
- iSmile Alginate Dustless Fast Set Impression Material Mint (1lb) FDA UDI
Identifiers
- Catalog Number
- 400012 FDA UDI
- Primary DI / UDI-DI
- H6684000121 FDA UDI
- 510(k) Number
- K940402 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 454 Gram FDA UDIWeight — 1 Pound FDA UDI
Category: Alginate dental impression material
iSmile by Harry J. Bosworth Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Alginate dental impression material.
- 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
- Essential Dustless alginate — HENRY SCHEIN, INC. · Class II
Cleared under the same submission
K940402 also covers:
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- Bosworth Supergel Fresh — Harry J. Bosworth Co.
- iSmile — Harry J. Bosworth Co.
- SmartPractice — SMART HEALTH LLC
- SmartPractice — SMART HEALTH LLC
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
- Harry J. Bosworth Co.
Sources (1)
- FDA UDI 83fd7304-4f31-4462-8026-57d6689d377e 38 fields · synced May 30, 2026