Identity
- Trade Name
- Absoanchor Microimplant FDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Model / Reference
- BH1817-10-L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806145401649 FDA UDI
- 510(k) Number
- K060126 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Orthodontic anchoring screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthodontic anchoring screw
Absoanchor Microimplant by DENTOS Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
- 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
- ORLUS MINI SCREW — Ortholution Co., Ltd. · Class II
- SA2008 — GNI Co., Ltd · Class II
Cleared under the same submission
K060126 also covers:
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
- Absoanchor Microimplant — DENTOS Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DENTOS Inc.
Sources (1)
- FDA UDI 0d0ab829-0391-46ad-9fd9-440184d15745 33 fields · synced May 31, 2026