Identity
- Trade Name
- HySil Super Fast Impression Materials FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Model / Reference
- ESS50HFB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800040673934 FDA UDI
- 510(k) Number
- K192941 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone dental impression material
HySil Super Fast Impression Materials by OSSTEM IMPLANT Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
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- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
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- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K192941 also covers:
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT Co., Ltd.
- HySil Super Fast Impression Materials — OSSTEM IMPLANT 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
- OSSTEM IMPLANT Co., Ltd.
Sources (1)
- FDA UDI cbb726aa-eaf6-47ef-9f07-d62224da34b4 33 fields · synced May 30, 2026