FDA.reportPublic FDA data

BluPrint

Primary DI
D74444989201
Brand
BluPrint
Company
BENCO DENTAL SUPPLY CO.
Model
4498-920
Device description
BluPrint Premium monophase fast set, mint flavor 2x50ml
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082560000PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACTKettenbach GmbH & Co. KG2008-09-08ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D74444989201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
015108087
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975012463GIBSON HEALTHCARE5250-9802018-05-31
00366975012470GIBSON HEALTHCARE5250-9992018-05-31
00366975012487GIBSON HEALTHCARE5251-0142018-05-31
00366975012494GIBSON HEALTHCARE5251-0232018-05-31
00366975012500GIBSON HEALTHCARE5251-0322018-06-04
00366975012517GIBSON HEALTHCARE5251-0412018-06-04
00366975012524GIBSON HEALTHCARE5251-0502018-06-04
00366975012531GIBSON HEALTHCARE5251-0692018-06-04
00366975012548GIBSON HEALTHCARE5251-1032018-06-04
00366975012555GIBSON HEALTHCARE5251-1122018-06-04
00366975012562GIBSON HEALTHCARE5251-1212018-06-04
00366975012678GIBSON HEALTHCARE5251-0782018-06-04
00366975012685GIBSON HEALTHCARE5251-0872018-06-04
00366975012692GIBSON HEALTHCARE5251-0962018-06-04
00366975012708GIBSON HEALTHCARE5251-1302018-06-04
00366975072108Sterling6904-7452026-08-27
00366975072115Sterling6904-7542026-08-27
00366975065506Natural Extensions5955-488N35PNK2026-07-30
00366975065513Natural Extensions5955-497N35PNK2026-07-30
00366975065520Natural Extensions5955-504N35PNK2026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998040481Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040511Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040542Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040573Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040603Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040658Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040689Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040719Solventum™ Paradigm™Solventum US LLCELW2026-10-17
00197998040764Solventum™ Paradigm™Solventum US LLCELW2026-10-17
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
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