FDA.reportPublic FDA data

M-PM Disc

Primary DI
D7091019275
Brand
M-PM Disc
Company
Merz Dental GmbH
Model
M-PM Disc, PMMA Disc, clear, thickness 20mm, diame
Catalog number
1019275
Device description
M-PM Disc, PMMA Disc, clear, thickness 20mm, diameter 98.5mm, pack of 5 pcs.
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134015000M-PM-DISCMerz Dental GmbH2014-04-11MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7091019275PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height20Millimeter
Outer Diameter98.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4943814030regulatory@merz-dental.de

Regulatory Flags#

DUNS number
324914910
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7091019183M-PM DiscM-PM Disc, PMMA-Disc, shade BL4 translucent ZIR th10191832016-09-24
D7091019186M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent ZIR thi10191862016-09-24
D7091019187M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent ZIR thi10191872016-09-24
D7091019188M-PM DiscM-PM Disc, PMMA-Disc, shade A3.5 translucent ZIR t10191882016-09-24
D7091019189M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent ZIR thi10191892016-09-24
D7091019236M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10192362020-04-07
D7091019237M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10192372020-04-07
D7091019238M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10192382020-04-07
D7091019239M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10192392020-04-07
D7091019240M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10192402020-04-07
D7091019420M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10194202019-12-05
D7091019421M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10194212019-12-05
D7091019422M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10194222019-12-05
D7091019423M-PM DiscM-PM Disc, PMMA-Disc, shade A3,5 translucent thick10194232019-12-05
D7091019424M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent thickne10194242019-12-05
D7091019425M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10194252019-12-05
D7091019426M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10194262019-12-05
D7091019427M-PM DiscM-PM Disc, PMMA-Disc, shade B3 translucent thickne10194272019-12-05
D7091019428M-PM DiscM-PM Disc, PMMA-Disc, shade B4 translucent thickne10194282019-12-05
D7091019429M-PM DiscM-PM Disc, PMMA-Disc, shade C1 translucent thickne10194292019-12-05

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