FDA.reportPublic FDA data

Xantasil Fast Set Bulk Pack 50X50ml

Primary DI
J014660675142
Brand
Xantasil Fast Set Bulk Pack 50X50ml
Company
Kulzer GmbH
Model
66067514
Catalog number
66067514
Published
2017-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J014660675142PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyether dental impression materialAn elastomeric, polyether-based material capable of reacting to form a rubber-like substance used 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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)431-1785xxx@xxx.xxx

Regulatory Flags#

DUNS number
315666321
Device count
1
DM exempt
true
Lot or batch
true

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J014661012770Retraxil blue66101277661012772026-04-21
J014661012780Retraxil blue66101278661012782026-04-21
J014660164550Starlight pro66016455660164552026-01-28
J014660573650Starlight pro66057365660573652026-01-28
J014660968300Starlight pro66096830660968302026-01-28
J014660969290Starlight pro66096929660969292026-01-28
J014660971690Starlight pro66097169660971692026-01-28
J014660971700Starlight pro66097170660971702026-01-28
J014661002680VENUS Diamond FLOW66100268661002682024-10-24
J014661002690VENUS Diamond FLOW66100269661002692024-10-24
J014661002700VENUS Diamond FLOW66100270661002702024-10-24
J014661002710VENUS Diamond FLOW66100271661002712024-10-24
J014661002720VENUS Diamond FLOW66100272661002722024-10-24
J014661002730VENUS Diamond FLOW66100273661002732024-10-24
J014661002740VENUS Diamond FLOW66100274661002742024-10-24
J014661002750VENUS Diamond FLOW66100275661002752024-10-24
J014661003060VENUS Diamond FLOW66100306661003062024-10-24

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08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
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08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
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08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
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08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08