Identity
- Trade Name
- Essential Dustless alginate FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- Dental impression material FDA UDI
- Model / Reference
- 1127285 FDA UDI
- Description
- Dental impression material FDA UDI
Identifiers
- Catalog Number
- 1127285 FDA UDI
- Primary DI / UDI-DI
- 00304040018712 FDA UDI
- 510(k) Number
- K011785 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Alginate dental impression material
Essential Dustless alginate by Henry Schein, Inc. — 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
K011785 also covers:
- Essential Dustless alginate — HENRY SCHEIN, INC.
- ESSENTIALS — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
- MDC Dental — MDC DENTAL
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI c4daef9f-06cb-4000-af14-3d1c55c0487e 36 fields · synced Jun 6, 2026