LuxaPrint Ortho NX 385 nm 171621

by DMG Digital Enterprises SE

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD9821716211 UDI-DI	Date26 May 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: LuxaPrint Ortho NX 385 nm
Generic Name: Dental appliance fabrication material, resin
Model / Ref / Catalog: 171621

Primary DI / UDI-DI: D9821716211
FDA Product Code: DYT
GMDN Term: Dental appliance fabrication material, resin

Device Class: Class I
Regulation Number: 872.5525
GUDID distribution status: In Commercial Distribution

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Class I
LuxaPrint Ortho Flex NX 171618

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LuxaPrint Ortho NX 385 nm 171620

Class I

See all devices from DMG Digital Enterprises SE →

Properties

Prescription Use
Premarket Exempt
Lot / Batch Number
Serial Number
Expiration Date

Other properties (9)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Manufacturing Date: No