FORMLABS OHIO INC.

Address:27800 Lemoyne Rd,Millbury,OH,43447,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Impression Tray, Resin (EBH) (2) Accessories, Implant, Dental, Endosseous (NDP) (1) Maintainer, Space Preformed, Orthodontic (DYT) (1) Positioner, Tooth, Preformed (KMY) (1)

Premarket Exempt

Yes

Clear

Surgical Guide - 00860002099309 Catalog Number :

Device Description : Surgical Guide Resin

Device Class :

Duns Number: 106744280

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : No

Device Count : 1

Custom Tray Resin - 00860002099323 Catalog Number : FLCTBL01

Device Class : 1

Duns Number: 106744280

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

Dental LT Clear Resin V2 - 00860002099330 Catalog Number : FLDLCL02

Device Class : 1

Duns Number: 106744280

Premarket Exempt : Yes

Product Code : KMY, DYT

Prescription Use : No

Device Count : 1

IBT Resin - 00860002099347 Catalog Number :

Device Description : IBT Resin is a light-curable polymer based material designed for 3D printing bio IBT Resin is a light-curable polymer based material designed for 3D printing biocompatible, indirect bonding trays for dental bracket placement. Users should independently verify the suitability of the printed materials for their particular application and intended purpose. IBT Resin is a photopolymer resin made of a mixture of methacrylic esters and photoinitiators.

Device Class : 1

Duns Number: 106744280

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

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