FDA.reportPublic FDA data

Polystar Selection EDITION HD

Primary DI
D7091983142
Brand
Polystar Selection EDITION HD
Company
Merz Dental GmbH
Model
posteriors; shade BL2; size S; upper jaw
Catalog number
1983142
Device description
posteriors; shade BL2; size S; upper jaw
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120404000MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbH2012-05-21ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7091983142PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494381403411claudia.bobrowski@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#

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D7091084040M-PRINT Surgical GuideM-PRINT Surgical guide ice-blue, 1000 g10840402022-02-18
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

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