Bone Level Healing Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
by Novodent SA
Identity
- Trade Name
- Bone Level Healing Abutment EUDAMEDImplantswiss FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Bone Level Healing Abutment EUDAMEDBone level Healing Abutment 5.5 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 UDI
- Model / Reference
- S-BHA5530 EUDAMEDFDA UDI
- Description
- Bone level Healing Abutment 5.5 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 UDI
Identifiers
- Catalog Number
- S-BHA5530 FDA UDI
- Primary DI / UDI-DI
- 07640168181444 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07640168181444 EUDAMED
- 510(k) Number
- K200867 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Bone Level Healing Abutment is a medical device used in orthopedic surgery to promote bone healing and reduce the risk of implant failure. By inserting an abutment into the patient's site, it helps guide the bone fragments together, promoting new bone growth and reducing the need for further surgery.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640168181444 | 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 (2)
- EUDAMED f1be8a50-99ab-4261-8517-cd4712fd3e83 61 fields · synced Aug 2, 2026
- FDA UDI c536ce69-ccfb-49da-9360-1a31059dcc1c 35 fields · synced May 30, 2026