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Us System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K062030

by Osstem Implant Co., Ltd.

Identity

Trade Name
US system FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Model / Reference
EHC100 FDA UDI

Identifiers

Primary DI / UDI-DI
08809892340896 FDA UDI
510(k) Number
K062030 FDA 510(k)FDA UDI
FDA Product Code
DZE FDA 510(k)FDA UDI
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Us System 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

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Manufacturer

Manufacturer
Osstem Implant Co., Ltd.

Sources (2)

  • FDA 510(k) K062030 24 fields · synced Jun 19, 2026
  • FDA UDI 22160ce9-5472-428d-bdac-696fa1f702e5 34 fields · synced May 26, 2026