Identity
- Trade Name
- HySil Impression Materials (Heavy, Mono, and Bite) FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Model / Reference
- ESS380M FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800040673873 FDA UDI
- 510(k) Number
- K181236 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 Impression Materials (Heavy +2 more) by OSSTEM IMPLANT Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 3 models
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Cleared under the same submission
K181236 also covers:
- HySil Impression Materials (Heavy, Mono, and Bite) — OSSTEM IMPLANT Co., Ltd.
- HySil Impression Materials (Heavy, Mono, and Bite) — OSSTEM IMPLANT Co., Ltd.
- HySil Impression Materials (Heavy, Mono, and Bite) — OSSTEM IMPLANT Co., Ltd.
- HySil Impression Materials (Heavy, Mono, and Bite) — OSSTEM IMPLANT Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- OSSTEM IMPLANT Co., Ltd.
Sources (2)
- FDA UDI 7be14b3a-add8-49e7-89de-b026f54518c8 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026