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Dental Impression and prosthetic components
EUDAMEDFDA UDIClass I (EU MDR)
Ref 069476003001601EZRef 069476003001501EURef 069476003001901FGRef 069476003002101EFRef 069476003002001EA
Identity
- Trade Name
- Dental Impression and prosthetic components EUDAMEDEquator Block-out Spacers FDA UDIWN Octagon plastic coping for WN Octagon1.5 , bridge FDA UDIRegular Scanbody for oral FDA UDIRN Plastic coping for RN Solid abutments, crown FDA UDIWN Octagon plastic coping for 033040, bridge FDA UDIMini Scanbody for model FDA UDIRN Octagon plastic coping for 032070, bridge FDA UDIRegular Scanbody for model FDA UDIWN Octagon plastic coping for WN Octagon1.5, crown FDA UDIExtension shell for RN Octagon 15° and 20° angled abutments FDA UDIScanbody for screw-retained abutment FDA UDIMini Scanbody for oral FDA UDIFixture Transfer Impression Coping,Regular,Non-Hex FDA UDI
- Generic Name
- Dental implant system FDA UDIDental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Dental Impression and prosthetic components EUDAMED
- Model / Reference
- 069476003001601EZ EUDAMED069476003001501EU EUDAMED069476003001901FG EUDAMED069476003002101EF EUDAMED069476003002001EA EUDAMED378070 V20 FDA UDI090110 FDA UDI362570 FDA UDI090020 FDA UDI090130 FDA UDI361320 FDA UDI090050 FDA UDI362580 FDA UDI090120 FDA UDI090070 FDA UDI362640U FDA UDI362640 FDA UDI361310 FDA UDI362540N FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947600302674 EUDAMED06947600312697 EUDAMEDFDA UDI06947600302643 EUDAMED06947600314974 EUDAMED06947600302681 EUDAMED06947600314455 EUDAMED06947600302636 EUDAMED06947600313670 EUDAMEDFDA UDI06947600302544 EUDAMEDFDA UDI06947600314523 EUDAMEDFDA UDI06947600302452 EUDAMEDFDA UDI06947600302568 EUDAMEDFDA UDI06947600314516 EUDAMEDFDA UDI06947600302483 EUDAMEDFDA UDI06947600314530 EUDAMEDFDA UDI06947600302551 EUDAMEDFDA UDI06947600302506 EUDAMEDFDA UDI06947600317845 EUDAMEDFDA UDI06947600314547 EUDAMEDFDA UDI06947600314509 EUDAMEDFDA UDI
- Basic UDI-DI
- 069476003001601EZ EUDAMED069476003001501EU EUDAMED069476003001901FG EUDAMED069476003002101EF EUDAMED069476003002001EA EUDAMED
- FDA Product Code
- NHA FDA UDIDZE FDA UDINDP FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Dental implant system FDA UDIDental implant abutment analog, intraoral-scanning, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3640 FDA UDI872.3980 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 UDIFDA 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 UDIFDA 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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDIFDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Dental Impression and prosthetic components by BIO CONCEPT Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 069476003001601EZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bio Concept Co., Ltd.
- EUDAMED SRN
- CN-MF-000019318
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (34)
- EUDAMED 13164135-7e8b-4b3e-9742-a0b018a5f654 61 fields · synced Sep 17, 2026
- EUDAMED 86b32ae0-9db4-4c0e-a472-9214b7cc9dba 61 fields · synced May 16, 2026
- EUDAMED 8724a8c4-b0c8-4317-be31-9ba0d0da1079 61 fields · synced May 17, 2026
- EUDAMED fada5d92-4376-4ce5-aeaa-86311f28a990 61 fields · synced May 19, 2026
- EUDAMED 7c880ad9-43f0-4822-bdf6-0e5077364e33 61 fields · synced May 19, 2026
- EUDAMED 2ae62e05-a0ca-43b8-afd5-413e989a5bab 61 fields · synced May 19, 2026
- EUDAMED 817f9017-cbdb-4b34-84f8-5ab5c838a9af 61 fields · synced May 19, 2026
- FDA UDI 0b06d39d-93c4-444d-84a9-9b7f2799aba2 33 fields · synced May 25, 2026
- FDA UDI 04fa7131-159f-464f-a9d0-0f417262c1ff 33 fields · synced May 30, 2026
- FDA UDI 4fca991b-f5ef-4515-a07f-8ebe5e2f5d09 32 fields · synced May 30, 2026
- FDA UDI 36e05df9-cca7-46fd-a39b-a09cc8fe7bed 33 fields · synced May 30, 2026
- FDA UDI 58a798c0-ff2a-472b-bbc3-b2da2dd77b6b 33 fields · synced May 30, 2026
- FDA UDI dda742b4-5c8d-49b6-8f7c-e4b8488357e0 32 fields · synced May 30, 2026
- FDA UDI d57faf04-b8b2-4122-a8e1-d91e3a879e26 33 fields · synced May 30, 2026
- FDA UDI 82478ca4-fa23-4dff-9549-0a4b04d183d8 32 fields · synced May 30, 2026
- FDA UDI 4b3739c1-b396-4742-8070-88f843f6b586 33 fields · synced May 30, 2026
- FDA UDI a25026d4-2a5d-40f0-b4cc-0b6893c93b7b 33 fields · synced May 30, 2026
- FDA UDI 78b77986-99e1-49a3-b12f-cf24451dd737 32 fields · synced May 30, 2026
- FDA UDI 92145baa-af5d-4db1-a32e-3d503ac0faa5 32 fields · synced May 30, 2026
- FDA UDI 2dc632a3-ffbb-4b01-b9ac-f33a01fc9bca 32 fields · synced May 30, 2026
- FDA UDI be3d946b-507f-457f-9965-361f99291c54 33 fields · synced May 30, 2026
- EUDAMED 17752234-10a9-4769-84ab-8796cb8b95a9 61 fields · synced Jul 9, 2026
- EUDAMED 150f6827-6d69-4e68-a7ad-0cf3ae8cc1a8 61 fields · synced Jul 12, 2026
- EUDAMED 0d4f8268-96b4-4b7f-9601-409a44efa2d3 61 fields · synced Jul 15, 2026
- EUDAMED 2dfd0734-5a47-47c2-9f52-06da379beead 61 fields · synced Jul 17, 2026
- EUDAMED e19ea0ed-c902-4c43-95c3-5dae9b8c49a1 61 fields · synced Jul 17, 2026
- EUDAMED 89d456a9-847c-4e15-8e7a-4e8f8d4edb86 61 fields · synced Jul 18, 2026
- EUDAMED a820dcf1-c008-400e-bc63-a817e77321cd 61 fields · synced Jul 19, 2026
- EUDAMED 8eba4d0b-e923-41b3-aded-df9741a933d1 61 fields · synced Jul 21, 2026
- EUDAMED 64d94358-4c92-4754-88f2-9f7877b9d747 61 fields · synced Jul 22, 2026
- EUDAMED 453075eb-78a0-48b1-9c6d-f245ee754e98 61 fields · synced Jul 23, 2026
- EUDAMED 6e4d8fbd-eadd-4595-a6e7-e9520b2d6179 61 fields · synced Jul 25, 2026
- EUDAMED 4713efa1-a12c-4f9d-91d6-a6f892357aea 61 fields · synced Aug 1, 2026
- EUDAMED 6cc34961-9b9f-4d69-aec9-209429d6a93b 61 fields · synced Aug 2, 2026