Identity
- Trade Name
- MDC Dental FDA UDI
- Generic Name
- Alginate dental impression material FDA UDI
- Device Name
- Type II normal setting alginate Metallic bag with 454 gr Removable and skeletal prostheses. Impression of removable, skeletal and total prosthodontics. Soft tissue impressions of the oral cavity and adjoining areas. FDA UDI
- Model / Reference
- Max Print Cyan FDA UDI
- Description
- Type II normal setting alginate Metallic bag with 454 gr Removable and skeletal prostheses. Impression of removable, skeletal and total prosthodontics. Soft tissue impressions of the oral cavity and adjoining areas. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07506338301060 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
Yes
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
MDC Dental by Mdc Dental — 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
- 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
K011785 also covers:
- Essential Dustless alginate — HENRY SCHEIN, INC.
- 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
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
- Mdc Dental
Sources (1)
- FDA UDI 5356b136-7e6e-4641-8443-d2c73db524b6 36 fields · synced Jun 1, 2026