Pmma Block
FDA UDIEUDAMEDClass U (US FDA UDI)
Identity
- Trade Name
- PMMA BLOCK EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- PMMA BLOCK EUDAMED
- Model / Reference
- Monolayer, Multilayer EUDAMEDMultilayer/98×30/2S/A3/1*1 EUDAMEDMultilayer/98×30/2S/2STB4/1*1 EUDAMEDMultilayer/98.5×40/2S/A3/1*1 EUDAMEDClear FDA UDI
Identifiers
- Catalog Number
- 13*1/BOX FDA UDI
- Primary DI / UDI-DI
- 06909412128644 EUDAMED06909412252103 EUDAMED06909412310766 EUDAMED06970402677497 FDA UDI
- Basic UDI-DI
- 6909412SZK2A0159 EUDAMED
- 510(k) Number
- K201683 FDA UDI
- FDA Product Code
- MQC FDA UDIEBI FDA UDIEBG FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3770 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Temporary dental crown/bridgePreformed complete dentureMouthguard, reusable
Pmma Block by Shandong Huge Dental Material Corporation — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mouthguard, reusable.
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- 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 (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| 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 (4)
- FDA UDI 6bab67e4-c5a9-4fa3-9059-e5db1b6d0388 34 fields · synced Sep 17, 2026
- EUDAMED 65686ca9-66f8-4d7c-b8a8-24bff20f4e56 61 fields · synced Sep 17, 2026
- EUDAMED 9e173faa-bb57-46bb-a9a2-0c19bc91eb69 61 fields · synced Sep 17, 2026
- EUDAMED 50419418-e2a2-49eb-a316-9bde57f4c03e 61 fields · synced Sep 17, 2026