← Back to catalogue

HySil Impression Materials

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K170736

by Osstem Implant Co., Ltd.

Identity

Trade Name
HySil Impression Materials FDA UDI
Generic Name
Silicone dental impression material FDA UDI
Model / Reference
ESS50MB FDA UDI

Identifiers

Primary DI / UDI-DI
08800000967714 FDA UDI
510(k) Number
K170736 FDA 510(k)FDA UDI
FDA Product Code
ELW FDA 510(k)FDA UDI
GMDN Term
Silicone dental impression material FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3660 FDA 510(k)
Regulation Number
872.3660 FDA 510(k)FDA UDI
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

HySil Impression Materials by Osstem Implant Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Osstem Implant Co., Ltd.

Sources (2)

  • FDA 510(k) K170736 24 fields · synced Jun 19, 2026
  • FDA UDI 103701f9-8b79-46ee-8d01-48bd3ad4f045 34 fields · synced May 26, 2026