Identity
- Trade Name
- Square Driver, 400 Series FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Square Driver, 400 Series FDA UDI
- Model / Reference
- 701-0036 FDA UDI
- Description
- Square Driver, 400 Series FDA UDI
Identifiers
- Catalog Number
- 701-0036 FDA UDI
- Primary DI / UDI-DI
- 00810118210358 FDA UDI
- 510(k) Number
- K230242 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant system
Square Driver, 400 Series by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
Cleared under the same submission
K230242 also covers:
- .050 Driver, Latch — OsteoCentric Technologies,Inc
- .050 Driver, Long — OsteoCentric Technologies,Inc
- .050 Driver, Short — OsteoCentric Technologies,Inc
- 3.7mm Parallel Pin — OsteoCentric Technologies,Inc
- 3.7mm Tap — OsteoCentric Technologies,Inc
- 3.7x10mm Implant Drill — OsteoCentric Technologies,Inc
- 3.7x12mm Implant Drill — OsteoCentric Technologies,Inc
- 3.7x8mm Implant Drill — OsteoCentric Technologies,Inc
- 4.2mm Parallel Pin — OsteoCentric Technologies,Inc
- 4.2mm Tap — OsteoCentric Technologies,Inc
- 4.2x10mm Implant Drill — OsteoCentric Technologies,Inc
- 4.2x12mm Implant Drill — OsteoCentric Technologies,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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI cbfe570b-beab-4a5a-9cbc-14744e43f460 36 fields · synced May 31, 2026