Med610

FDA UDI

Class I (US FDA UDI)

by Stratasys Ltd

Identity

Trade Name: MED610 FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays. MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose. MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity. FDA UDI
Model / Reference: MED610 1Kg FDA UDI
Description: MED610™ is a light-curable polymerizable material intended to fabricate, by additive manufacturing, parts used in the production of dental surgical guides; and indirect bonding trays. The indirect bonding trays produced are suitable for dental indications including orthodontic indirect bonding trays. MED610™ is intended exclusively for professional dental work. Users should independently verify the suitability of the material for their particular application and intended purpose. MED610™ is not intended for long term use (up to 24 hours only) within the oral cavity. FDA UDI

Identifiers

Catalog Number: OBJ-04078 FDA UDI
Primary DI / UDI-DI: 07290018915219 FDA UDI
FDA Product Code: QJJ FDA UDI
NDP FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental appliance fabrication material, resin

Med610 by Stratasys Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Stratasys Ltd

Sources (1)

FDA UDI 043f8e26-b574-4630-8020-594914a3dba5 35 fields · synced May 30, 2026