Identity
- Trade Name
- OP FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- One Piece™ Implant Ø3.0 X 15mm FDA UDI
- Model / Reference
- OP3015 FDA UDI
- Description
- One Piece™ Implant Ø3.0 X 15mm FDA UDI
Identifiers
- Catalog Number
- OP3015 FDA UDI
- Primary DI / UDI-DI
- D742OP3015 FDA UDI
- 510(k) Number
- K130140 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant system 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
No
FDA UDI
Category: Dental implant system
Op by Intra-Lock International — Class II — 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
K130140 also covers:
- Intra-Lock — Intra-Lock International
- Intra-Lock — Intra-Lock International
- Intra-Lock — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
- OP — Intra-Lock International
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
- Intra-Lock International
Sources (1)
- FDA UDI 1d928d95-a4ca-4a0e-af00-0fc91cf06127 36 fields · synced May 30, 2026