Identity
- Trade Name
- SA1608 FDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Model / Reference
- SA1608 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046000567 FDA UDI
- FDA Product Code
- OAT 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthodontic anchoring screw
Sa1608 by GNI Co., Ltd — 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
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
- GNI Co., Ltd
Sources (1)
- FDA UDI 52938000-1f40-4119-8fe5-a9df9b645513 32 fields · synced Jun 8, 2026