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Synthetic Polymer Teeth
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref KAIFENG/S4-L6-34/B3/28×1Model Upper anterior teeth, Lower anterior teeth, Posterior teethRef Select/T6/B3/6×1×16Ref KAIFENG/T9/C3/6×1Ref MAIST/O2/C2/6×1Ref Delux/L4/D2/6×1×16Ref Delux/I33L/A3/8×1Ref Delux/IO2/A3/6×1Ref KAIFENG/L3/A00/6×1Ref Delux/IT2/D2/6×1×16Ref KAIFENG/S4/D4/6×1×16Ref KAIFENG/S4-L7-36/C1/28×1×4Ref MAIST/32SU/A2/8×1×12Ref MAIST/30ML/A2/8×1Ref Select/L11/A3/6×1×16Ref MAIST/30MU/B2/8×1×12Ref KAIFENG/T7/D3/6×1
Identity
- Trade Name
- Synthetic Polymer Teeth EUDAMEDFDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Synthetic Polymer Teeth EUDAMED
- Model / Reference
- Upper anterior teeth, Lower anterior teeth, Posterior teeth EUDAMEDKAIFENG/S4-L6-34/B3/28×1 EUDAMEDSelect/T6/B3/6×1×16 EUDAMEDKAIFENG/T9/C3/6×1 EUDAMEDMAIST/O2/C2/6×1 EUDAMEDDelux/L4/D2/6×1×16 EUDAMEDDelux/I33L/A3/8×1 EUDAMEDDelux/IO2/A3/6×1 EUDAMEDKAIFENG/L3/A00/6×1 EUDAMEDDelux/IT2/D2/6×1×16 EUDAMEDKAIFENG/S4/D4/6×1×16 EUDAMEDKAIFENG/S4-L7-36/C1/28×1×4 EUDAMEDMAIST/32SU/A2/8×1×12 EUDAMEDMAIST/30ML/A2/8×1 EUDAMEDSelect/L11/A3/6×1×16 EUDAMEDMAIST/30MU/B2/8×1×12 EUDAMEDKAIFENG/T7/D3/6×1 EUDAMEDBLUEBELL FDA UDIKAIPLUS FDA UDI
Identifiers
- Catalog Number
- 1*6*16 FDA UDI
- Primary DI / UDI-DI
- 06909412291454 EUDAMED06909412313231 EUDAMED06909412299597 EUDAMED06909412269392 EUDAMED06909412206335 EUDAMED06909412204058 EUDAMED06909412202771 EUDAMED06909412300910 EUDAMED06909412209053 EUDAMED06909412282070 EUDAMED06909412287730 EUDAMED06909412265356 EUDAMED06909412273634 EUDAMED06909412213425 EUDAMED06909412264328 EUDAMED06909412299443 EUDAMED06970402676896 FDA UDI06970402676933 FDA UDI
- Basic UDI-DI
- 6909412RZY2A019J EUDAMED
- 510(k) Number
- K101029 FDA UDI
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q01020601 MOBILE DENTAL PROSTHESES EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 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: Resin artificial teeth
Synthetic Polymer Teeth by Shandong Huge Dental Material Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Resin artificial teeth.
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Cleared under the same submission
K101029 also covers:
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
- MASSAD — CMP INDUSTRIES LLC
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shandong Huge Dental Material Corporation
Sources (18)
- FDA UDI a885c3bb-1892-408f-88e3-d8e5d976ceff 34 fields · synced Oct 7, 2026
- FDA UDI 01eff5c5-9878-417b-9517-b69cb205ee30 34 fields · synced May 25, 2026
- EUDAMED fa85dda6-da2a-4298-a978-fb53ed123918 61 fields · synced Sep 17, 2026
- EUDAMED 614f2ee2-9d12-47bc-b725-07041726c8d2 61 fields · synced Sep 17, 2026
- EUDAMED ca9f85a0-cd18-47d1-9fd6-e1f1bbcaa565 61 fields · synced Sep 17, 2026
- EUDAMED 29e6fae5-9287-4246-b0b1-039f55d193f4 61 fields · synced Sep 17, 2026
- EUDAMED c3b11929-aec6-4b42-96f9-ee1f50f5509b 61 fields · synced Sep 17, 2026
- EUDAMED f49d7b3b-3a61-470f-9d96-27f20ff00923 61 fields · synced Sep 17, 2026
- EUDAMED b9b1db71-feda-4b8b-a658-2c7fa172a396 61 fields · synced Sep 17, 2026
- EUDAMED 94d18ba1-6c39-4ea2-b8f1-5a194ad93a18 61 fields · synced Sep 17, 2026
- EUDAMED c33029bc-9eb8-4513-b216-2ad67fdecc55 61 fields · synced Sep 17, 2026
- EUDAMED bb170456-f1f9-491c-9b08-683c8f4a5f9b 61 fields · synced Sep 17, 2026
- EUDAMED 6fadfc1e-76c2-47bd-ad97-8264414c6c91 61 fields · synced Sep 17, 2026
- EUDAMED 0e0c4117-27cf-4dd2-9dd9-8b19bb1a3a66 61 fields · synced Sep 17, 2026
- EUDAMED 831ad977-8f34-4e64-94a0-0c4501930494 61 fields · synced Sep 17, 2026
- EUDAMED 6c0e5927-4efb-4de5-b706-4c41a94a963b 61 fields · synced Sep 17, 2026
- EUDAMED 1db7918d-5fb3-49ea-9329-9260718fb0f0 61 fields · synced Sep 30, 2026
- EUDAMED 16ae2296-6bb8-49a8-89eb-70e04a6a9594 61 fields · synced Sep 30, 2026