Identity
- Trade Name
- HAPTITE s-Clean tapered Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L12.0mm FDA UDI
- Model / Reference
- DSFW4812H FDA UDI
- Description
- Dental Implant System / HAPTITE s-Clean tapered Fixture D4.8mm X L12.0mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806169107732 FDA UDI
- 510(k) Number
- K111364 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece 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: Screw endosteal dental implant, two-piece
HAPTITE s-Clean tapered Fixture by Dentis Co. , Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
- ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
- LW Solid Abutment — Ossvis Co., Ltd. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
- UF(II) Wide — DIO Corporation · Class II
Cleared under the same submission
K111364 also covers:
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean SAVE Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean straight Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean straight Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean straight Fixture — DENTIS CO. , LTD
- HAPTITE i-Clean straight Fixture — DENTIS CO. , LTD
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
- Dentis Co. , Ltd
Sources (1)
- FDA UDI b29f3635-dedd-4013-a7a5-4da937b215db 34 fields · synced Jun 8, 2026