I-FIX Angled Type ScanBody
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- I-FIX Angled Type ScanBody EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDI-FIX Angled Type ScanBody (DFASBS) FDA UDII-FIX Angled Type ScanBody (DFASBSS) FDA UDII-FIX Angled Type ScanBody (DFASBLS) FDA UDI
- Model / Reference
- DFASBSS EUDAMEDFDA UDIDFASBLS EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDFASBS FDA UDI
- Description
- I-FIX Angled Type ScanBody (DFASBS) FDA UDII-FIX Angled Type ScanBody (DFASBSS) FDA UDII-FIX Angled Type ScanBody (DFASBLS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053064750 EUDAMEDFDA UDI08800053064767 EUDAMEDFDA UDI08800053064729 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 abutment analog, intraoral-scanning, 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 abutment analog, intraoral-scanning, single-use
I-FIX Angled Type ScanBody by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 (5)
- FDA UDI ae3b3767-15dd-4fbd-bfa4-a6c46afbfda3 33 fields · synced Jul 24, 2026
- FDA UDI e6e8be07-c37c-43af-a895-7dfeafeec829 33 fields · synced May 26, 2026
- FDA UDI 48a05cbf-80a5-4618-bb1d-a9799b78a755 33 fields · synced May 30, 2026
- EUDAMED cf8e4bf1-64c4-4c3d-bcf9-115e818beb94 61 fields · synced Jul 9, 2026
- EUDAMED 54cf8df4-2e4e-4339-a282-4fae508f5be0 61 fields · synced Jul 24, 2026