M-PM Crystal

FDA UDI

Class U (US FDA UDI)

by Merz Dental GmbH

Identity

Trade Name: M-PM Crystal FDA UDI
Generic Name: Removable dental occlusal splint, custom-made FDA UDI
Device Name: M-PM crystal, diameter 95 mm, thickness 20 mm FDA UDI
Model / Reference: M-PM crystal, 95mm x 20mm FDA UDI
Description: M-PM crystal, diameter 95 mm, thickness 20 mm FDA UDI

Identifiers

Catalog Number: 1019255 FDA UDI
Primary DI / UDI-DI: D7091019255 FDA UDI
FDA Product Code: MQC FDA UDI
GMDN Term: Removable dental occlusal splint, custom-made FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 95 Millimeter FDA UDI
Height — 20 Millimeter FDA UDI

Category: Removable dental occlusal splint, custom-made

M-PM Crystal by Merz Dental GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Removable dental occlusal splint, custom-made.

ProPlan CMF — Materialise NV · Class I
Primeprint Splint SF 1000g — DETAX GmbH · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
Freeprint ortho 405 1000g — DETAX GmbH · Class I
Vertex-Dental BV — Vertex-Dental B.V. · Class I
IMPRIMO LC Splint comfort — Pro3Dure Medical · Class I
BENCO — BENCO DENTAL SUPPLY CO. · Class I
Primeprint Splint — DETAX GmbH · 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 U	Pending data

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Manufacturer

Manufacturer: Merz Dental GmbH

Sources (1)

FDA UDI 225b82e0-984b-4f0e-83d9-58f871a9805f 36 fields · synced Jun 8, 2026