CeraRoot Implant System

FDA UDI

Class I (US FDA UDI)

by Ceraroot Sl.

Identity

Trade Name: CeraRoot Implant System FDA UDI
Generic Name: Orthopaedic implant impactor, reusable FDA UDI
Device Name: Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to position the CeraRoot 14 into the alveolar bone. Its mode of application is by transmission of an impact force to drive the implant into its final position in the bone. The proximal end is a handle designed to absorb the impact from a surgical hammer or mallet. The distal end is shaped curved to conform to the implant shape and is made of PEEK. This is a reusable device. FDA UDI
Model / Reference: 005.214 FDA UDI
Description: Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to position the CeraRoot 14 into the alveolar bone. Its mode of application is by transmission of an impact force to drive the implant into its final position in the bone. The proximal end is a handle designed to absorb the impact from a surgical hammer or mallet. The distal end is shaped curved to conform to the implant shape and is made of PEEK. This is a reusable device. FDA UDI

Identifiers

Catalog Number: 005.214 FDA UDI
Primary DI / UDI-DI: 08435453900515 FDA UDI
510(k) Number: K093595 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic implant impactor, reusable

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

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Cleared under the same submission

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 I	Pending data

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Manufacturer

Manufacturer: Ceraroot Sl.

Sources (1)

FDA UDI cb71cb77-6252-4dda-ba8c-588a80133b04 36 fields · synced May 30, 2026