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M-PM Disc

FDA UDI

Class II (US FDA UDI)

by Merz Dental GmbH

Identity

Trade Name
M-PM Disc FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
M-PM Disc, PMMA-Disc, shade pink thickness 25mm, diameter 98,5mm FDA UDI
Model / Reference
M-PM Disc, PMMA-Disc, shade pink thickness 25mm, diameter 98,5mm FDA UDI
Description
M-PM Disc, PMMA-Disc, shade pink thickness 25mm, diameter 98,5mm FDA UDI

Identifiers

Catalog Number
1019208 FDA UDI
Primary DI / UDI-DI
D7091019208 FDA UDI
510(k) Number
K140758 FDA UDI
FDA Product Code
EBG FDA UDI
EBI FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3770 FDA UDI
872.3760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Height — 25 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Dental appliance fabrication material, thermoplastic

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

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Cleared under the same submission

K140758 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merz Dental GmbH

Sources (1)

  • FDA UDI 76b6f897-7a72-4ad5-9315-d2800f7a834f 37 fields · synced Jun 1, 2026