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ScanBody Screw Bar
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DSSBSBH4Model DENTIS Implant Surgical Instrument SystemRef DSSBSBC4Ref DSSBSBQ4Ref DSSBSBH
Identity
- Trade Name
- ScanBody Screw Bar EUDAMEDFDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDScanBody Screw Bar (DSSBSBC4) FDA UDIScanBody Screw Bar (DSSBSBQ) FDA UDIScanBody Screw Bar (DSSBSBQ4) FDA UDIScanBody Screw Bar (DSSBSBH4) FDA UDIScanBody Screw Bar (DSSBSBH) FDA UDI
- Model / Reference
- DSSBSBC4 EUDAMEDFDA UDIDSSBSBQ4 EUDAMEDFDA UDIDSSBSBH4 EUDAMEDFDA UDIDSSBSBH EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMEDDSSBSBQ FDA UDI
- Description
- ScanBody Screw Bar (DSSBSBC4) FDA UDIScanBody Screw Bar (DSSBSBQ) FDA UDIScanBody Screw Bar (DSSBSBQ4) FDA UDIScanBody Screw Bar (DSSBSBH4) FDA UDIScanBody Screw Bar (DSSBSBH) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800266941145 EUDAMEDFDA UDI08800266941107 EUDAMEDFDA UDI08800266941121 EUDAMEDFDA UDI08800266941114 EUDAMEDFDA UDI08800266941091 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
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 abutment analog, intraoral-scanning, single-use
ScanBody Screw Bar 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
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 (9)
- FDA UDI 38bd7cb7-3876-4ea2-b67d-0fad79c932ae 33 fields · synced Sep 17, 2026
- FDA UDI 61cdab00-49d7-4a3a-a4ef-8b4909d7e962 33 fields · synced May 25, 2026
- FDA UDI bed1c21c-71de-4bd1-b05c-6c1032f82299 33 fields · synced May 29, 2026
- FDA UDI 2109d055-e974-4548-bea1-31839ab6a953 33 fields · synced May 30, 2026
- FDA UDI 1af6836f-0ba3-42a9-bba9-0271684a8c98 33 fields · synced May 30, 2026
- EUDAMED 1955603e-8f1c-4df8-8ff6-c8751177b420 61 fields · synced Jul 8, 2026
- EUDAMED fddd4e9c-1b9b-4314-8e22-c71ba03c3e5f 61 fields · synced Jul 9, 2026
- EUDAMED 93046ee8-82b8-4cae-adab-3d12e7371f6a 61 fields · synced Jul 18, 2026
- EUDAMED 20ac3b6e-3247-4c03-9044-53e91a570bc8 61 fields · synced Sep 17, 2026