← Back to catalogue

CeraRoot Implant System

FDA UDI

Class I (US FDA UDI)

by Ceraroot Sl.

Identity

Trade Name
CeraRoot Implant System FDA UDI
Generic Name
Dental implant system FDA UDI
Device Name
Right Angle / Handpiece Adapter 4x4 - steel FDA UDI
Model / Reference
001.007 FDA UDI
Description
Right Angle / Handpiece Adapter 4x4 - steel FDA UDI

Identifiers

Catalog Number
001.007 FDA UDI
Primary DI / UDI-DI
08435453900355 FDA UDI
510(k) Number
K093595 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental implant system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3980 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

CeraRoot Implant System by Ceraroot Sl. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K093595 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Ceraroot Sl.

Sources (1)

  • FDA UDI 8368eb5d-1ae5-4eda-b90e-d7e61e56d9c7 37 fields · synced May 30, 2026