I-FIX Angled Type Impression Coping
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- I-FIX Angled Type 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-FIX Angled Type Impression Coping FDA UDI
- Model / Reference
- DMIC12S EUDAMEDFDA UDIDMIC23S EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDMIC23 EUDAMEDDMIC18 EUDAMED
- Description
- Dental Implant Instrument / I-FIX Angled Type Impression Coping FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169144232 EUDAMEDFDA UDI08806169144256 EUDAMEDFDA UDI08806169141774 EUDAMED08806169141767 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
I-FIX Angled Type 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
MDR
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 (6)
- FDA UDI 39cbec36-941b-4a6e-bf9a-da05a5415b95 33 fields · synced Jul 23, 2026
- FDA UDI 23dfcf88-1cab-4513-baf2-1f29842c7f8e 33 fields · synced May 30, 2026
- EUDAMED 3aa52ecd-6913-4f4f-b687-4af29e5de333 61 fields · synced Jul 8, 2026
- EUDAMED 8d6dcf99-f1fe-4c10-9ff6-6151bcb9e33b 61 fields · synced Jul 9, 2026
- EUDAMED 90fd043d-9319-4711-8fda-b3f11d60a980 61 fields · synced Jul 20, 2026
- EUDAMED 69b6e4b0-b970-429e-a1cc-38a0072514e2 61 fields · synced Jul 23, 2026