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s-Clean Impression Positioning Cylinder
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DSIPC65Model DENTIS Implant Surgical Instrument SystemRef DSIPC455Ref DSIPC555Ref DSIPC657Ref DSIPCS407Ref DSIPC654
Identity
- Trade Name
- s-Clean Impression Positioning Cylinder EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / s-Clean Impression Positioning Cylinder FDA UDI
- Model / Reference
- DSIPC455 EUDAMEDFDA UDIDSIPCS407 EUDAMEDFDA UDIDSIPC65 EUDAMEDFDA UDIDSIPC654 EUDAMEDFDA UDIDSIPC657 EUDAMEDFDA UDIDSIPC555 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSIPCS405 FDA UDI
- Description
- Dental Implant Instrument / s-Clean Impression Positioning Cylinder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053037921 EUDAMEDFDA UDI08800053037914 EUDAMEDFDA UDI08800053039444 EUDAMEDFDA UDI08800053039482 EUDAMEDFDA UDI08800053038096 EUDAMEDFDA UDI08800053037945 EUDAMEDFDA UDI08800053038089 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 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 Impression Positioning Cylinder 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 (13)
- FDA UDI 70cfdac8-33e7-46e1-877a-6920dd90465b 33 fields · synced Sep 17, 2026
- FDA UDI b82ea20b-e53d-4029-9aa5-b684b843db9f 33 fields · synced May 29, 2026
- FDA UDI 1b239c78-4b75-4298-996b-f5b2d21a3ce5 33 fields · synced May 30, 2026
- FDA UDI 02562568-b894-46ae-80f0-85ae0e386709 33 fields · synced May 30, 2026
- FDA UDI 4ffd8c54-859b-4b2d-8eed-47c200d35297 33 fields · synced May 30, 2026
- FDA UDI bc0a1893-8f29-4371-b9bc-721f3e745b3b 33 fields · synced May 30, 2026
- FDA UDI 20611b71-42d1-4ffa-bc3d-704e5f3dee82 33 fields · synced May 30, 2026
- EUDAMED 68f554a5-97bf-4dab-b37e-83a209417185 61 fields · synced Jul 14, 2026
- EUDAMED 4a0f2513-b87a-4a2e-94d1-e1b7c3673988 61 fields · synced Jul 15, 2026
- EUDAMED e8c912c3-af58-44a6-b864-a82c53caf3db 61 fields · synced Jul 20, 2026
- EUDAMED 13b30dbb-cbad-4f1a-9b37-79e2bf1598f4 61 fields · synced Jul 31, 2026
- EUDAMED 743982ed-d084-446f-a67e-87a7ad55d2dd 61 fields · synced Aug 1, 2026
- EUDAMED 50795493-f629-433a-963d-2d35f888d32a 61 fields · synced Sep 17, 2026