FDA.report

Lucitone Digital IPN 3D Premium Tooth

Primary DI
D0039063850
Brand
Lucitone Digital IPN 3D Premium Tooth
Company
Dentsply Professional
Model
906385
Catalog number
906385
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PZYAdditively manufactured, preformed, resin denture tooth

Product Code Classifications

CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0039063850PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
144140845
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D0013035701Ceramco 33035703035702024-10-03
D0013036301Ceramco 33036303036302024-10-03
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D0013039201Ceramco 33039203039202024-10-03
D0013050011Ceramco 33050013050012024-10-02
D0013050051Ceramco 33050053050052024-10-02
D0013050201Ceramco 33050203050202024-10-02
D0013050221Ceramco 33050223050222024-10-02
D0013051041Ceramco 33051043051042024-10-02
D0013051151Ceramco 33051153051152024-10-02
D0013051211Ceramco 33051213051212024-10-03
D0013051321Ceramco 33051323051322024-10-02
D0013051331Ceramco 33051333051332024-10-02
D0013051371Ceramco 33051373051372024-10-02
D0013051381Ceramco 33051383051382024-10-02

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28056865155658ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
28056865155665ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
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06971437944806UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
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06971437944820UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944837UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944844UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944851UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
06971437944868UltraPrint Denture Teeth UVGUANGZHOU HEYGEARS IMC.INCPZY2026-01-14
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