FDA.report

Burkhart VPS Fast Set Putty (2x300ml Tubs)

Primary DI
00815878021152
Brand
Burkhart VPS Fast Set Putty (2x300ml Tubs)
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72720439
Device description
Putty Material (VPS)
Published
2018-11-09
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815878021152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815878021152008158780211528158780211520815878021152

GMDN Terms

TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
800-562-8176customerservice@burkhartdental.com

Regulatory Flags

DUNS number
027532357
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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