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s-Clean Sole Abutment Lab Analog
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DSSLA45Model DENTIS Implant Surgical Instrument SystemRef DSSLAS404Ref DSSLA454Ref DSSLA457Ref DSSLA60LRef DSSLA554Ref DSSLA557Ref DSSLA657
Identity
- Trade Name
- s-Clean Sole Abutment Lab Analog EUDAMEDFDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / s-Clean Sole Abutment Lab Analog FDA UDI
- Model / Reference
- DSSLA657 EUDAMEDFDA UDIDSSLA60L EUDAMEDFDA UDIDSSLA557 EUDAMEDFDA UDIDSSLAS404 EUDAMEDFDA UDIDSSLA554 EUDAMEDFDA UDIDSSLA45 EUDAMEDFDA UDIDSSLA454 EUDAMEDFDA UDIDSSLA457 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSSLA48L FDA UDI
- Description
- Dental Implant Instrument / s-Clean Sole Abutment Lab Analog FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053014991 EUDAMEDFDA UDI08800053039093 EUDAMEDFDA UDI08800053015004 EUDAMEDFDA UDI08800053039499 EUDAMEDFDA UDI08800053039086 EUDAMEDFDA UDI08800053037983 EUDAMEDFDA UDI08800053039062 EUDAMEDFDA UDI08800053014984 EUDAMEDFDA UDI08800053039079 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 analog 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 UDIFDA 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 analog
s-Clean Sole Abutment Lab Analog by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (17)
- FDA UDI d93f6668-ff6b-47e9-a1ec-d4f8812e4b02 33 fields · synced Jul 28, 2026
- FDA UDI c6e1190a-8bef-4061-a02d-a22052390a6d 33 fields · synced May 29, 2026
- FDA UDI 99b8dd77-d1df-4b78-bef1-69a1c92365cb 33 fields · synced May 30, 2026
- FDA UDI 3a17e09e-f5a2-4209-b09e-2444060f5eb1 33 fields · synced May 30, 2026
- FDA UDI a5945803-3618-479e-8de3-62d0bcda96be 33 fields · synced May 30, 2026
- FDA UDI 882731af-aafc-4154-bf2b-54ecae478e99 33 fields · synced May 30, 2026
- FDA UDI fa6b92c9-fe3d-4c6c-9ebe-fe72b58b37e9 33 fields · synced May 30, 2026
- FDA UDI 23875704-ff15-4099-83d7-caf00dd7a01a 33 fields · synced May 30, 2026
- FDA UDI e18c4dbd-0ee3-4bd5-8802-aff4fe1729b7 33 fields · synced May 30, 2026
- EUDAMED d3d70cb5-3c6e-465f-a7e2-718a7def7da5 61 fields · synced Jul 9, 2026
- EUDAMED 10e4303a-c0b3-4318-ae41-baff7fd5ab58 61 fields · synced Jul 11, 2026
- EUDAMED dbd2cb7a-0832-48e4-a771-1d98da2eb760 61 fields · synced Jul 12, 2026
- EUDAMED abded085-a74c-4b6a-aaee-f34c46ebd48d 61 fields · synced Jul 14, 2026
- EUDAMED 39a83ea2-7bfa-4689-ac21-269229262cd8 61 fields · synced Jul 18, 2026
- EUDAMED efbd9df3-0807-4c34-8e30-51d28ffc6082 61 fields · synced Jul 26, 2026
- EUDAMED 4b802e4c-1176-456b-8c67-1934d043426c 61 fields · synced Jul 28, 2026
- EUDAMED a62490de-3ee9-4c93-bf50-8ed8709720cb 61 fields · synced Jul 28, 2026