FDA.report

VITACOLL

Primary DI
J017A9C1000
Brand
VITACOLL
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
A9C100
Device description
VITACOLL, 100 ml
Published
2023-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NSKDentures, partial

Product Code Classifications

CodeDeviceSpecialtyClass
NSKDentures, PartialUnknownN

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
J017A9C1000PrimaryHIBCC0

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

Contacts

PhoneEmail
+1(800)8283839info@vitanorthamerica.com

Regulatory Flags

DUNS number
315165357
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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J01701075880n!ce® Zirconia GT010.75882026-01-22
J01701075890n!ce® Zirconia GT010.75892026-01-22

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