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i-Clean Octa Pick-Up Impression Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DIOIWOZModel DENTIS Implant Surgical Instrument SystemRef DIOINZSRef DIOIWNZRef DIOINZRef DIOIWNRef DIOIOSRef DIOIWNZSRef DIOINSRef DIOIWNSRef DIOIWOS
Identity
- Trade Name
- i-Clean Octa Pick-Up 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 Pick-Up Impression Coping FDA UDI
- Model / Reference
- DIOIOS EUDAMEDFDA UDIDIOIWOS EUDAMEDFDA UDIDIOIWNS EUDAMEDFDA UDIDIOINS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDIOIWOZ EUDAMEDDIOINZS EUDAMEDDIOIWNZ EUDAMEDDIOINZ EUDAMEDDIOIWN EUDAMEDDIOIWNZS EUDAMED
- Description
- Dental Implant Instrument / i-Clean Octa Pick-Up Impression Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169143655 EUDAMEDFDA UDI08806169143662 EUDAMEDFDA UDI08806169143648 EUDAMEDFDA UDI08806169143631 EUDAMEDFDA UDI08800053033848 EUDAMED08800053034043 EUDAMED08800053033862 EUDAMED08800053033855 EUDAMED08806169141927 EUDAMED08800053034050 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
i-Clean Octa Pick-Up 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 13f6e990-d85f-4fa4-93bd-8b95163b1a62 33 fields · synced Aug 2, 2026
- FDA UDI bd1ee50a-d3e4-4a29-8401-495512cea7fc 33 fields · synced May 29, 2026
- FDA UDI 489d99f9-19a9-464e-b38c-eec280a598c3 33 fields · synced May 30, 2026
- FDA UDI 064e50aa-c81d-404f-afc8-bcef2e8dab70 33 fields · synced May 30, 2026
- EUDAMED 47ed0f58-9b35-4a0b-89cf-13265adb40b1 61 fields · synced Jul 9, 2026
- EUDAMED 72ff8cad-e1f6-4168-8f4f-2b2e0c6e56d7 61 fields · synced Jul 11, 2026
- EUDAMED 4933627b-d5ef-41ef-9f9e-e5379fe1f968 61 fields · synced Jul 11, 2026
- EUDAMED 459d558a-d99f-4c28-8e58-f61dd302334a 61 fields · synced Jul 17, 2026
- EUDAMED 508df2aa-b53d-4a5b-aa14-843615d25d14 61 fields · synced Jul 18, 2026
- EUDAMED 91b428a0-41fd-453f-bd92-52fadd96b655 61 fields · synced Jul 21, 2026
- EUDAMED 710ae61f-8158-4fa8-ba36-6aae94b4561e 61 fields · synced Jul 25, 2026
- EUDAMED 8b2b8cd4-fe7d-4b97-87f9-d13e2005918a 61 fields · synced Jul 26, 2026
- EUDAMED 16f7166b-eb58-4802-824a-0ac63fd464d8 61 fields · synced Aug 1, 2026
- EUDAMED 8b79ca41-de3d-4e7f-8e7a-0b891eeb2f92 61 fields · synced Aug 2, 2026