Identity
- Trade Name
- SMARTFIT PROVISONAL DENTURE FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- PROHYM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810126043191 FDA UDI
- 510(k) Number
- K171585 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Smartfit Provisonal Denture by Hiossen Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K171585 also covers:
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX CO., LTD
- LUXEN Smile — DENTALMAX 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 |
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Manufacturer
- Manufacturer
- Hiossen Inc.
Sources (1)
- FDA UDI 0ac865c6-3a2a-491e-85a8-2e2d1d956dd3 33 fields · synced May 31, 2026