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i-Clean Shoulder Analog Pin
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DIISAW65Model DENTIS Implant Surgical Instrument SystemRef DIISAW65SRef DISAPRRef DIISAR
Identity
- Trade Name
- i-Clean Shoulder Analog Pin EUDAMEDFDA UDIi-Clean Shoulder Analog EUDAMEDFDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / i-Clean Shoulder Analog Pin FDA UDIi-Clean Shoulder Analog FDA UDIDental Implant Instrument / i-Clean Shoulder Analog FDA UDI
- Model / Reference
- DISAPR EUDAMEDFDA UDIDIISAR EUDAMEDFDA UDIDIISAW65 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDIISAW65S EUDAMED
- Description
- Dental Implant Instrument / i-Clean Shoulder Analog Pin FDA UDIi-Clean Shoulder Analog FDA UDIDental Implant Instrument / i-Clean Shoulder Analog FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053023023 EUDAMEDFDA UDI08800053039185 EUDAMEDFDA UDI08800053039192 EUDAMEDFDA UDI08800053039956 EUDAMED
- 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 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
i-Clean Shoulder Analog Pin 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 (7)
- FDA UDI 0f640f83-cd26-4187-b649-ae585f1590cf 33 fields · synced Jul 17, 2026
- FDA UDI b7a6fbdb-289c-4f7e-8fb4-fb76b8cab016 33 fields · synced May 30, 2026
- FDA UDI 5edb8e62-5b47-48a1-8333-70d77329a76e 33 fields · synced May 30, 2026
- EUDAMED bd52a89b-1cc0-4778-8860-ad1c34355677 61 fields · synced Jul 9, 2026
- EUDAMED e5db492d-dbf4-4113-932b-5ec9a219315e 61 fields · synced Jul 10, 2026
- EUDAMED b87bffa1-4f4d-4b6f-954f-6de322afe2fa 61 fields · synced Jul 14, 2026
- EUDAMED bb876a4f-7e49-479e-846d-04721485b780 61 fields · synced Jul 17, 2026