Identity
- Trade Name
- PMMA BLOCK FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Model / Reference
- Multilayer FDA UDI
Identifiers
- Catalog Number
- 10*1/BOX FDA UDI
- Primary DI / UDI-DI
- 06970402677305 FDA UDI
- 510(k) Number
- K201683 FDA UDI
- FDA Product Code
- MQC FDA UDIEBI FDA UDIEBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3770 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
Category: Temporary dental crown/bridgePreformed complete dentureMouthguard, reusable
Pmma Block by Shandong Huge Dental Material Corporation — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mouthguard, reusable.
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- AESCULAP — AESCULAP, INC. · Class I
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- Orofacial Therapeutics — TRUER MEDICAL, INC. · U
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · Class II
Cleared under the same submission
K201683 also covers:
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- BioTemps — PRISMATIK DENTALCRAFT, INC.
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION
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 U | Pending data |
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Manufacturer
- Manufacturer
- Shandong Huge Dental Material Corporation
Sources (1)
- FDA UDI ba87f3d3-d008-4af5-a7e6-713390909269 34 fields · synced Jun 8, 2026