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s-Clean Plastic UCLA Abutment
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DSPCNModel DENTIS Implant Surgical Instrument SystemRef DEPWHRef DEPRN
Identity
- Trade Name
- s-Clean Plastic UCLA Abutment EUDAMEDFDA UDIe-Clean Plastic UCLA Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / s-Clean Plastic UCLA Abutment (DSPCHMS) FDA UDIDental Implant Instrument / e-Clean Plastic UCLA Abutment D5.5mm X L13.0mm / Hex FDA UDIDental Implant Instrument / e-Clean Plastic UCLA Abutment D4.5mm X L13.0mm / Non-Hex FDA UDIDental Implant Instrument / s-Clean Plastic UCLA Abutment D4.5mm / Non-Hex FDA UDI
- Model / Reference
- DEPWH EUDAMEDFDA UDIDEPRN EUDAMEDFDA UDIDSPCN EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSPCHMS FDA UDI
- Description
- Dental Implant Instrument / s-Clean Plastic UCLA Abutment (DSPCHMS) FDA UDIDental Implant Instrument / e-Clean Plastic UCLA Abutment D5.5mm X L13.0mm / Hex FDA UDIDental Implant Instrument / e-Clean Plastic UCLA Abutment D4.5mm X L13.0mm / Non-Hex FDA UDIDental Implant Instrument / s-Clean Plastic UCLA Abutment D4.5mm / Non-Hex FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169103895 EUDAMEDFDA UDI08806169103888 EUDAMEDFDA UDI08806169110268 EUDAMEDFDA UDI08800053043670 FDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDINHA FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA UDI
- Regulation Number
- 872.3980 FDA UDI872.3630 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 suprastructure, permanent, preformed
s-Clean Plastic UCLA Abutment by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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- EZ Post — Megagen Implant Co. Ltd · Class II
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 6086e409-33eb-4e13-b930-583e7af3b488 33 fields · synced Jul 30, 2026
- FDA UDI 2ecac916-a961-442c-a567-2359649a7c1d 33 fields · synced May 30, 2026
- FDA UDI bb5d5f3d-62e5-4ebd-917e-7bf6124ba80e 33 fields · synced May 30, 2026
- FDA UDI a16621de-98d4-4f5d-8dba-44deb6dee47b 33 fields · synced May 30, 2026
- EUDAMED 35a979df-f9b7-4f02-a7a3-5a27ff7ae7cb 61 fields · synced Jul 15, 2026
- EUDAMED 7fda4d5b-bf1b-4baf-afb0-92dea82b325a 61 fields · synced Jul 23, 2026
- EUDAMED 66ab28df-960e-441d-acf4-91e115955ab1 61 fields · synced Jul 30, 2026