Identity
- Trade Name
- ANCHOR PLUS/NEO ANCHOR PLUS FDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Model / Reference
- MS-1607 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809488210121 FDA UDI
- 510(k) Number
- K053629 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic anchoring screw
Anchor Plus/Neo Anchor Plus by Kj Meditech — 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
- 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
Cleared under the same submission
K053629 also covers:
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
- ANCHOR PLUS/NEO ANCHOR PLUS — Kj Meditech
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 |
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Manufacturer
- Manufacturer
- Kj Meditech
Sources (1)
- FDA UDI bce47ccf-bfea-4d2f-9c64-5a07ec35b19f 33 fields · synced Jun 8, 2026