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Bone Level Mini Couple Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref S-BMCA37207Ref S-BMCAN3730Ref S-BMCA37407Ref S-BMCA37507Ref S-BMCA3740Ref S-BMCAN37507Ref S-BMCAN37107Ref S-BMCAN3710Ref S-BMCA3750Ref S-BMCAN3720Ref S-BMCA3710Ref S-BMCAN37207
by Novodent SA
Identity
- Trade Name
- Bone Level Mini Couple Abutment EUDAMEDBone Level Mini Couple Abutment Non-Hex EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Bone Level Mini Couple Abutment EUDAMEDBone Level Mini Couple Abutment Non-Hex EUDAMEDBone level Mini Couple Abutment 3.7 x 1.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment H7 3.7 x 4.0 x H7mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment H7 3.7 x 2.0 x H7mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment 3.7 x 5.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment Non-Hex 3.7 x 1.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment H7 3.7 x 5.0 x H7mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment 3.7 x 4.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment Non-Hex 3.7 x 3.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment Non-Hex 3.7 x 2.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDI
- Model / Reference
- S-BMCA37207 EUDAMEDFDA UDIS-BMCAN3730 EUDAMEDFDA UDIS-BMCA37407 EUDAMEDFDA UDIS-BMCA37507 EUDAMEDFDA UDIS-BMCA3740 EUDAMEDFDA UDIS-BMCAN37507 EUDAMEDS-BMCAN37107 EUDAMEDS-BMCAN3710 EUDAMEDFDA UDIS-BMCA3750 EUDAMEDFDA UDIS-BMCAN3720 EUDAMEDFDA UDIS-BMCA3710 EUDAMEDFDA UDIS-BMCAN37207 EUDAMED
- Description
- Bone level Mini Couple Abutment 3.7 x 1.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment H7 3.7 x 4.0 x H7mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment H7 3.7 x 2.0 x H7mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment 3.7 x 5.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment Non-Hex 3.7 x 1.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment H7 3.7 x 5.0 x H7mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment 3.7 x 4.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment Non-Hex 3.7 x 3.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDIBone level Mini Couple Abutment Non-Hex 3.7 x 2.0 mm "Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Abutment: The part of the system that makes the link between the implant part and the prosthetic super structure." FDA UDI
Identifiers
- Catalog Number
- S-BMCA3710 FDA UDIS-BMCA37407 FDA UDIS-BMCA37207 FDA UDIS-BMCA3750 FDA UDIS-BMCAN3710 FDA UDIS-BMCA37507 FDA UDIS-BMCA3740 FDA UDIS-BMCAN3730 FDA UDIS-BMCAN3720 FDA UDI
- Primary DI / UDI-DI
- 07640168189136 EUDAMEDFDA UDI07640168180423 EUDAMEDFDA UDI07640168189297 EUDAMEDFDA UDI07640168189303 EUDAMEDFDA UDI07640168180232 EUDAMEDFDA UDI07630188205848 EUDAMED07630188202700 EUDAMED07640168180409 EUDAMEDFDA UDI07640168180249 EUDAMEDFDA UDI07640168180416 EUDAMEDFDA UDI07640168180201 EUDAMEDFDA UDI07630188202717 EUDAMED
- Basic UDI-DI
- B-07640168189136 EUDAMEDB-07640168180423 EUDAMEDB-07640168189297 EUDAMEDB-07640168189303 EUDAMEDB-07640168180232 EUDAMEDB-07630188205848 EUDAMEDB-07630188202700 EUDAMEDB-07640168180409 EUDAMEDB-07640168180249 EUDAMEDB-07640168180416 EUDAMEDB-07640168180201 EUDAMEDB-07630188202717 EUDAMED
- 510(k) Number
- K181266 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Türkiye EUDAMEDSweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 UDIFDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Bone Level Mini Couple Abutment by Novodent SA — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640168189136 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (33)
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- FDA UDI 9ac530a9-d9bf-4293-9901-9fa02d2a3554 36 fields · synced May 29, 2026
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