Identity
- Trade Name
- PMMA BLOCK FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Model / Reference
- Shade: C2; Spec:98*10mm; Net Weight:87g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975187610134 FDA UDI
- 510(k) Number
- K223706 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 Huliang(Shanghai) Biotech Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mouthguard, reusable.
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- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
- AESCULAP — AESCULAP, INC. · Class I
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
- PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
- GrindRelief PRO — Grind Guard Technologies, L.L.C. · U
Cleared under the same submission
K223706 also covers:
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
- PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huliang(Shanghai) Biotech Co., Ltd.
Sources (1)
- FDA UDI de2efb3f-b144-4756-b010-0d4216ba90ce 33 fields · synced May 30, 2026