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DENTIS GUIDE Anchor Screw
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref DGAS18Model DENTIS Implant Surgical Instrument System
Identity
- Trade Name
- DENTIS GUIDE Anchor Screw EUDAMEDFDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Device Name
- DENTIS Implant Surgical Instrument System EUDAMEDDental Implant Instrument / DENTIS GUIDE Anchor Screw FDA UDI
- Model / Reference
- DGAS18 EUDAMEDFDA UDIDENTIS Implant Surgical Instrument System EUDAMED
- Description
- Dental Implant Instrument / DENTIS GUIDE Anchor Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053012188 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061691DENTIS-I7L EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Orthodontic anchoring screw 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: Orthodontic anchoring screw
DENTIS GUIDE Anchor Screw by Dentis Co. , Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic anchoring screw.
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
- Absoanchor Microimplant — DENTOS Inc. · Class II
- Absoanchor Microimplant — DENTOS Inc. · Class II
- GBR System Bone Screw — Jeil Medical Corporation · Class II
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
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 (2)
- FDA UDI 0518458e-f958-4fa6-947c-61db5141fae7 33 fields · synced Jun 20, 2026
- EUDAMED 4285814f-d7b4-4712-ad53-d835b329a6e5 61 fields · synced Jun 20, 2026