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s-Clean Solid Type PS Abutment
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DPSA4515Model DENTIS Implant Surgical Instrument SystemRef DPSA5525
Identity
- Trade Name
- s-Clean Solid Type PS Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment trial FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / s-Clean Solid Type PS Abutment FDA UDI
- Model / Reference
- DPSA4515 EUDAMEDFDA UDIDPSA5525 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDPSS6535 FDA UDI
- Description
- Dental Implant Instrument / s-Clean Solid Type PS Abutment FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169139825 EUDAMEDFDA UDI08806169139856 EUDAMEDFDA UDI08806169139795 FDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant abutment trial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA 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 UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant abutment trial
s-Clean Solid Type PS Abutment by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment trial.
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- FRIADENT® — Dentsply Implants Manufacturing GmbH · Class I
- Scan Cap — Megagen Implant Co. Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (5)
- FDA UDI 6ae468d2-6734-4a25-9279-e83de8272348 33 fields · synced Jul 27, 2026
- FDA UDI 51c33df7-5321-41b4-8333-2fcdfc606b75 33 fields · synced May 22, 2026
- FDA UDI dd7adbbe-a06a-402d-99e2-44e9742edb70 33 fields · synced May 30, 2026
- EUDAMED c731dbdc-b243-48fc-ba63-0646247b7439 61 fields · synced Jul 13, 2026
- EUDAMED 164f0404-6530-4dd3-a3ae-f73664a1954e 61 fields · synced Jul 27, 2026