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: Transporter 21 - steel for the CeraRoot 21 implant FDA UDI
Model / Reference: 005.021 FDA UDI
Description: Transporter 21 - steel for the CeraRoot 21 implant FDA UDI

Identifiers

Catalog Number: 005.021 FDA UDI
Primary DI / UDI-DI: 08435453900485 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Dimensions & Sizes

Size: Outer Diameter — 6 Millimeter FDA UDI

Category: Dental implant system

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

Similar devices

Also classified as Dental implant system.

Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · Class II

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

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

Manufacturer

Manufacturer: Ceraroot Sl.

Sources (1)

FDA UDI 08f17ed4-75cd-4a10-b483-20e950b8bd66 37 fields · synced May 30, 2026