Identity
- Trade Name
- STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing/Closure Screw EUDAMEDNC Healing abutment, bottle shape, D 3.3mm, H 5mm, Ti FDA UDI
- Model / Reference
- 024.2236S EUDAMEDHealing / Closure Screws FDA UDI
- Description
- NC Healing abutment, bottle shape, D 3.3mm, H 5mm, Ti FDA UDI
Identifiers
- Catalog Number
- 024.2236S FDA UDI
- Primary DI / UDI-DI
- 07630031700674 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170065QW EUDAMED
- 510(k) Number
- K130808 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 3.3 Millimeter FDA UDI
The Healing/Closure Screw is a medical device designed for suturing, featuring a unique closure mechanism that provides reliable and secure attachment of tissue to the implant site. This device has been approved by regulatory agencies worldwide and is used in various surgical procedures to facilitate healing and minimize scarring.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763003170065QW | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (2)
- EUDAMED 61912fca-4bd1-479e-8fce-854444149d2b 61 fields · synced Aug 2, 2026
- FDA UDI 327f5bfb-a24b-4d3e-8352-acfbba8a842c 38 fields · synced May 30, 2026