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Healing/Closure Screw
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 064.8511SRef 064.8512SRef 064.8217SRef 064.4101SRef 064.8513SRef 064.4243SRef 064.8514SRef 064.8218SRef 036.2202S
Identity
- Trade Name
- Straumann TLX Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing/Closure Screw EUDAMEDWT Healing Cap, Ø7.2mm, H2mm, Ti FDA UDI
- Model / Reference
- 064.8511S EUDAMED064.8512S EUDAMED064.8217S EUDAMED064.4101S EUDAMED064.8513S EUDAMED064.4243S EUDAMED064.8514S EUDAMED064.8218S EUDAMED036.2202S EUDAMEDHealing Components FDA UDI
- Description
- WT Healing Cap, Ø7.2mm, H2mm, Ti FDA UDI
Identifiers
- Catalog Number
- 036.2202S FDA UDI
- Primary DI / UDI-DI
- 07630031779793 EUDAMED07630031779809 EUDAMED07630031779083 EUDAMED07630031778994 EUDAMED07630031779816 EUDAMED07630031779052 EUDAMED07630031779823 EUDAMED07630031779090 EUDAMED07630031746412 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170065QW EUDAMED
- 510(k) Number
- K200586 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 2 Millimeter FDA UDIOuter Diameter — 7.2 Millimeter FDA UDI
Healing/Closure Screw by Institut Straumann AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 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 (10)
- EUDAMED f50bafc5-6c6f-4021-9ab6-1542531946aa 61 fields · synced Jul 29, 2026
- EUDAMED 72107903-8234-4496-8a6f-fbe0e438a0a7 61 fields · synced May 17, 2026
- EUDAMED e6b2aae3-eb78-4df2-beb7-76b68e174357 61 fields · synced May 17, 2026
- EUDAMED 27e1dc87-bacc-40b0-a5d6-ed7e37e16871 61 fields · synced May 17, 2026
- EUDAMED 3531cfeb-0445-4b29-88a8-6be1bc82b761 61 fields · synced May 17, 2026
- EUDAMED 91471009-a8f9-4d7c-8957-e8089dc46b8b 61 fields · synced May 18, 2026
- EUDAMED d77f6877-c116-44d0-85d3-f3b78bb83d9d 61 fields · synced May 18, 2026
- EUDAMED 371c6fb9-6fc2-4a75-848e-b078e6180529 61 fields · synced May 18, 2026
- EUDAMED 336f09f8-8ff6-4dfa-ba34-2f7380756464 61 fields · synced May 18, 2026
- FDA UDI febd24ef-7a17-462b-9581-29034de0ff9a 38 fields · synced May 29, 2026