FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
00810132800580
Brand
House Brand Dentistry
Company
Frontier Dental Supply Inc
Model
HSB-210100
Device description
Bite Registration Impression Material 2/Pk Fast Set Unflavored
Published
2023-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K201684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201684000A-Silicone for Bite RegistrationShandong Huge Dental Material Corporation2020-09-24ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810132800580PrimaryGS10
10810132800587Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132800580008101328005808101328005800810132800580
1081013280058710810132800587

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203768304
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810132800610House Brand DentistryHSB-1005612026-02-13
10810132809986House Brand DentistryHSB-1005612026-02-13
00810132808128House Brand DentistryHSB-1091202026-02-10
00810132809446House Brand DentistryHSB-4113012026-02-10
00810132808135House Brand DentistryHSB-1091202026-02-10
10810132809443House Brand DentistryHSB-4113012026-02-10
00810189432451House Brand DentistryHSB-1005742025-09-02
10810189432458House Brand DentistryHSB-1005742025-09-02
00810132800603House Brand DentistryHSB-1005602025-08-29
00810132809941House Brand DentistryHSB-1005702025-08-29
00810189432420House Brand DentistryHSB-1005712025-08-29
00810189432437House Brand DentistryHSB-1005722025-08-29
00810132809958House Brand DentistryHSB-1005602025-08-29
10810132809948House Brand DentistryHSB-1005702025-08-29
10810189432427House Brand DentistryHSB-1005712025-08-29
10810189432434House Brand DentistryHSB-1005722025-08-29
00810132802089House Brand DentistryHSB-1005332025-08-06
00810132802133House Brand DentistryHSB-1005332025-08-06
00810132808050House Brand DentistryHSB-1002352025-08-05
00810132808203House Brand DentistryHSB-1002222025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
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