Roott

FDA UDI

Class I (US FDA UDI)

by Trate Llc

Identity

Trade Name: ROOTT FDA UDI
Generic Name: Dental implant analog FDA UDI
Device Name: Implant analog, R. FDA UDI
Model / Reference: AN FDA UDI
Description: Implant analog, R. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810149980121 FDA UDI
FDA Product Code: NDP FDA UDI
GMDN Term: Dental implant analog 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant analog

Roott by Trate Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Blue Sky Bio, LLC — BLUE SKY BIO LLC · Class I
DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I

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: Trate Llc

Sources (1)

FDA UDI 3644521a-3b77-4ccf-8c70-a8861c161e65 34 fields · synced May 30, 2026