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s-Clean Sole Abutment Plastic Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DSSAP55BModel DENTIS Implant Surgical Instrument SystemRef DSSP45SRef DSHP60HRef DSSASP40SRef DSSP60BRef DSSASP40BRef DSSAP65BRef DSSP48SRef DSHP45HRef DSSP60SRef DSSAP55SRef DSSP65BRef DSSP55BRef DSSAP65SRef DSSAP45BRef DSHP60N
Identity
- Trade Name
- s-Clean Plastic coping EUDAMEDs-Clean Sole Abutment Plastic Coping FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / s-Clean Sole Abutment Plastic Coping FDA UDI
- Model / Reference
- DSSP65B EUDAMEDFDA UDIDSSAP45B EUDAMEDFDA UDIDSSP48S EUDAMEDFDA UDIDSSASP40S EUDAMEDFDA UDIDSSAP65S EUDAMEDFDA UDIDSSP45S EUDAMEDFDA UDIDSSASP40B EUDAMEDFDA UDIDSSP55B EUDAMEDFDA UDIDSSAP55S EUDAMEDFDA UDIDSSAP65B EUDAMEDFDA UDIDSSP60S EUDAMEDFDA UDIDSSP60B EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSSAP55B EUDAMEDDSHP60H EUDAMEDDSHP45H EUDAMEDDSHP60N EUDAMED
- Description
- Dental Implant Instrument / s-Clean Sole Abutment Plastic Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053039291 EUDAMEDFDA UDI08800053037990 EUDAMEDFDA UDI08800053039314 EUDAMEDFDA UDI08800053038027 EUDAMEDFDA UDI08800053038058 EUDAMEDFDA UDI08800053039307 EUDAMEDFDA UDI08800053038126 EUDAMEDFDA UDI08800053039277 EUDAMEDFDA UDI08800053038041 EUDAMEDFDA UDI08800053038010 EUDAMEDFDA UDI08800053039338 EUDAMEDFDA UDI08800053039284 EUDAMEDFDA UDI08800053038003 EUDAMED08800053040211 EUDAMED08800053040242 EUDAMED08800053040174 EUDAMED
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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 suprastructure, temporary, preformed, single-use
s-Clean Sole Abutment Plastic Coping 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 suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY 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 (28)
- FDA UDI 671aa031-04d7-42ca-a66d-8bc19508c4aa 33 fields · synced Aug 2, 2026
- FDA UDI 8533fe1c-9ee3-413f-9c85-19bd4fcab10f 33 fields · synced May 30, 2026
- FDA UDI 3800a67d-25e4-4536-b416-29393de0f83d 33 fields · synced May 30, 2026
- FDA UDI 49bf35d5-0208-467b-817f-e5412bdfb036 33 fields · synced May 30, 2026
- FDA UDI d4b4632d-3314-4aac-b947-7c55bd22fadc 33 fields · synced May 30, 2026
- FDA UDI a161214a-4173-4054-9ec8-6cbac666a51a 33 fields · synced May 30, 2026
- FDA UDI aee1d6b3-f375-4856-8958-592071d3c6b9 33 fields · synced May 30, 2026
- FDA UDI cf94b02d-0539-45c2-821a-6f1cc3ddf5a7 33 fields · synced May 30, 2026
- FDA UDI 65b707d2-a75b-472a-94e5-5c668c7e252e 33 fields · synced May 30, 2026
- FDA UDI 4ce76a17-fe52-488c-b4b7-828f7207b90c 33 fields · synced May 30, 2026
- FDA UDI 83936c45-8825-401e-b7d7-b247e487ab86 33 fields · synced May 30, 2026
- FDA UDI cbc97d33-b0ea-47f2-945e-be9168ab4ec0 33 fields · synced May 30, 2026
- EUDAMED 69836e88-505d-4711-af5f-5363aae43be3 61 fields · synced Jul 8, 2026
- EUDAMED 0b25fad0-56b0-4291-88d2-573210aacce2 61 fields · synced Jul 9, 2026
- EUDAMED 53f40c43-5321-4aea-a142-2d275145d3e7 61 fields · synced Jul 9, 2026
- EUDAMED deeb7e9b-5602-4394-b490-5b6b5e8c24ea 61 fields · synced Jul 10, 2026
- EUDAMED 4eb08021-3149-436a-9a7a-79b0c1b270d8 61 fields · synced Jul 13, 2026
- EUDAMED c5dcac13-5a37-44ba-b9a2-69113543b78e 61 fields · synced Jul 15, 2026
- EUDAMED c6347a7f-f6e1-4e74-8d0a-61f82a4cc5b0 61 fields · synced Jul 15, 2026
- EUDAMED d0af9a09-a7de-4fe8-b075-bf4fd6d73139 61 fields · synced Jul 15, 2026
- EUDAMED 61164d90-a801-45a9-9a8c-c6752f84efa5 61 fields · synced Jul 17, 2026
- EUDAMED ad57ec27-2bdf-4334-a241-8733917b6a1f 61 fields · synced Jul 20, 2026
- EUDAMED 786944ff-c355-4405-989b-05a636df049a 61 fields · synced Jul 24, 2026
- EUDAMED 6f428389-c1a9-4ac6-a02d-295268d35c44 61 fields · synced Jul 25, 2026
- EUDAMED 0eadbe97-689e-43f7-850c-063d6fb1338d 61 fields · synced Jul 27, 2026
- EUDAMED 14a2df39-c735-4f87-8250-b9ee95c9476e 61 fields · synced Jul 28, 2026
- EUDAMED 255de91d-3424-4fb7-83bb-cc53113b2ae8 61 fields · synced Jul 29, 2026
- EUDAMED d0721fe8-10e2-4cf1-94d7-e4481c02c1b3 61 fields · synced Aug 2, 2026