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i-Clean Octa Transfer Impression Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DIOTIWNZSModel DENTIS Implant Surgical Instrument SystemRef DIOTIWORef DIOTIZRef DIOTIWNSRef DIOTIOZSRef DIOTIWNRef DIOTISRef DIOTIWOZSRef DIOTIOSRef DIOTIOZ
Identity
- Trade Name
- i-Clean Octa Transfer Impression Coping EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / i-Clean Octa Transfer Impression Coping FDA UDI
- Model / Reference
- DIOTIS EUDAMEDFDA UDIDIOTIWNS EUDAMEDFDA UDIDIOTIOS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDIOTIWNZS EUDAMEDDIOTIWO EUDAMEDDIOTIZ EUDAMEDDIOTIOZS EUDAMEDDIOTIWN EUDAMEDDIOTIWOZS EUDAMEDDIOTIOZ EUDAMEDDIOTIWOS FDA UDI
- Description
- Dental Implant Instrument / i-Clean Octa Transfer Impression Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169143679 EUDAMEDFDA UDI08806169143686 EUDAMEDFDA UDI08806169143693 EUDAMEDFDA UDI08800053034098 EUDAMED08806169141989 EUDAMED08800053033893 EUDAMED08800053034067 EUDAMED08806169141965 EUDAMED08800053034074 EUDAMED08800053033879 EUDAMED08806169143709 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
i-Clean Octa Transfer Impression 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 (14)
- FDA UDI 6a17dd35-b11b-419c-b9a6-f6e58da3f77b 33 fields · synced Aug 5, 2026
- FDA UDI c2a1420f-35f1-4e4d-bd73-1ae0f2788c14 33 fields · synced May 29, 2026
- FDA UDI 4ae2339c-5d6c-4967-b5f2-0d5f3f6bc792 33 fields · synced May 30, 2026
- FDA UDI 19ffc81c-e0ff-443f-a6a4-bc342a3735f2 33 fields · synced May 30, 2026
- EUDAMED 383c190c-cc48-45ea-8777-ac45b69c150f 61 fields · synced Jun 20, 2026
- EUDAMED 985d7671-bd76-4114-b0ec-7c6d9dddd4b9 61 fields · synced Jul 8, 2026
- EUDAMED 9f4446d2-407d-4b98-a7e2-168d075a6f46 61 fields · synced Jul 9, 2026
- EUDAMED c349b6f7-3b9e-41a4-80e5-73fbaab9e33e 61 fields · synced Jul 9, 2026
- EUDAMED 1790c84d-2c29-46ab-bcd0-11070e4ad14b 61 fields · synced Jul 10, 2026
- EUDAMED 7fb9ebe9-f43a-48c2-8589-b3c243b7606f 61 fields · synced Jul 13, 2026
- EUDAMED 13612fc1-da0a-4dc6-bab9-f310bb009dde 61 fields · synced Jul 14, 2026
- EUDAMED 961bb35f-bbfa-42a7-ab2f-b0514f77318e 61 fields · synced Jul 23, 2026
- EUDAMED 3d3f7716-7cdf-4e73-b13b-e1d8adaffdea 61 fields · synced Aug 2, 2026
- EUDAMED 1ef5e52e-22ad-4c16-b616-5b4d353d1465 61 fields · synced Aug 5, 2026