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Pmma Block
FDA UDIEUDAMEDClass U (US FDA UDI)
Ref Monolayer/98×20/2S/A1/1*1Model Monolayer, MultilayerRef Monolayer/98×20/2S/A2/1*1Ref Monolayer/98×20/2S/A3/1*1Ref Multilayer/95×10/ /A3/1*1Ref Multilayer/98×12/2S/C2/1*1Ref Multilayer/98×40/2S/3SA2/1*1Ref Multilayer/98×20/2S/2SA2/1*1Ref Multilayer/95×25/ /B1/1*1
Identity
- Trade Name
- PMMA BLOCK EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- PMMA BLOCK EUDAMED
- Model / Reference
- Monolayer, Multilayer EUDAMEDMonolayer/98×20/2S/A1/1*1 EUDAMEDMonolayer/98×20/2S/A2/1*1 EUDAMEDMonolayer/98×20/2S/A3/1*1 EUDAMEDMultilayer/95×10/ /A3/1*1 EUDAMEDMultilayer/98×12/2S/C2/1*1 EUDAMEDMultilayer/98×40/2S/3SA2/1*1 EUDAMEDMultilayer/98×20/2S/2SA2/1*1 EUDAMEDMultilayer/95×25/ /B1/1*1 EUDAMEDMonolayer FDA UDI
Identifiers
- Catalog Number
- 20*1/BOX FDA UDI
- Primary DI / UDI-DI
- 06909412119185 EUDAMED06909412119192 EUDAMED06909412119208 EUDAMED06909412136489 EUDAMED06909412128309 EUDAMED06909412253650 EUDAMED06909412250413 EUDAMED06909412137837 EUDAMED06970402677206 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mouthguard, reusable.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · Class II
- Nylon Nightguard/Occlusal Appliance — SERENA SLEEP SOLUTIONS LLC · U
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
- AESCULAP — AESCULAP, INC. · Class I
- GrindRelief PRO — Grind Guard Technologies, L.L.C. · U
- 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (9)
- FDA UDI 18e7f8fd-3536-45a3-b658-d793d5e43a16 34 fields · synced Aug 1, 2026
- EUDAMED bd8132ce-d7e9-4837-a356-dfaf1d8bfb51 61 fields · synced Jul 10, 2026
- EUDAMED c38be809-904b-4136-82a9-2a85347cdb54 61 fields · synced Jul 25, 2026
- EUDAMED f9930327-07da-4149-9a65-e7a5ed46316f 61 fields · synced Jul 28, 2026
- EUDAMED 70295347-096d-4dcd-a10a-4c1cfffe28aa 61 fields · synced Aug 1, 2026
- EUDAMED e5344d04-c757-490d-9b14-bf469b0977a5 61 fields · synced Aug 1, 2026
- EUDAMED 3df10803-c24a-4d0e-b98c-e6cdb07e6556 61 fields · synced Aug 1, 2026
- EUDAMED c1ccba54-78b1-4a9c-89c4-052ce29e4f78 61 fields · synced Aug 1, 2026
- EUDAMED 4d141260-21b6-4add-ac71-4b8ab2e92700 61 fields · synced Aug 1, 2026