FDA.reportPublic FDA data

PIT AND FISSURE SEALANT CLEAR 4-1ML SYRINGES

Primary DI
D8281330231
Brand
PIT AND FISSURE SEALANT CLEAR 4-1ML SYRINGES
Company
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Model
1330231
Published
2016-09-24
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
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093059000SELECT DEFENSE DENTAL PIT AND FISSURE SEALANTClassone Orthodontics, Inc.2010-02-04EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8281330231PrimaryHIBCC0
D82813302312Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental pit/fissure sealantA resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113352686
Device count
4
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D82850001900Twin Block50001902022-12-30
D82853004020Rickonator53004022022-12-09
D82851006000Tri-Aligner51006002023-02-13
D82851001560Bioliner Plus51001562023-02-10
D82850001910Removable Rickonator50001912023-01-13
D82853003720LVI Anterior Remodeling Appliance53003722023-01-13
D82852000100Incisor Blocks52000102023-01-03
D82853003010Snap Fit RPE53003012022-12-28
D82853000300Distal Shoe Space Maintainer53000302022-12-13
D82853002850Self-Activating Memory RPE53002852022-12-13
D82853002890Memory RPE53002892022-12-13
D82853002930RPE53002932022-12-13
D82853002950Skeletal Expander53002952022-12-13
D82853002980Bilateral Leone Distalizer53002982022-12-13
D82853002990Unilateral Expander53002992022-12-13
D82853003000Bondable R.P.E. - No Bands53003002022-12-13
D82853003110Haas Appliance53003112022-12-13
D82853003330Five Star Fixed Expander - Upper53003332022-12-13
D82853003340Five Star Mixed Dent Expander- Upper53003342022-12-13
D82853003350Five Star Mixed Dent Expander- Lower53003352022-12-13

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Primary DI, Brand, Company table
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08806387860068Jet Flow Bulk A2Meta Biomed Co., Ltd.EBC2024-11-16
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08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
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07615208294217Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208301335Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2023-04-06
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D79645420MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
D7964542CS1MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
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D757C52410KEU1eCementBISCO INC.EBC2021-06-25
00815619021526EXACTA Flow-lcEXACTA DENTAL PRODUCTS INCEBC2019-02-01