FDA.reportPublic FDA data

BEYOND® BlueSeal® Gingival Protection (5 pack)

Primary DI
00857848007209
Brand
BEYOND® BlueSeal® Gingival Protection (5 pack)
Company
Beyond International Inc.
Model
BY-PD02205
Published
2022-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857848007209PrimaryGS10
00857848007766Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857848007209008578480072098578480072090857848007209
00857848007766008578480077668578480077660857848007766

GMDN Terms#

Term, Definition table
TermDefinition
Gingiva bleaching protectorA non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
080721790
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857848007094GeminiBY-GM2242023-05-08
00857848007124BEYOND® Polus® Advanced Whitening AcceleratorPLS-868A 2022-12-23
00857848007131BEYOND® II Whitening AcceleratorBE-8182022-12-23
00857848007216BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)BY-PD01205M2022-12-23
00857848007223BEYOND® FlexiBlue® Comfort Cheek Retractors (5 pack)BY-PD01205L2022-12-23
00857848007292BEYOND® II Cheek Retractor (5 pack)BY-M0122022-12-23
00857848007315BEYOND® BlueSeal® Gingival Protection Twin PackBY-PD022022022-12-23
00857848007599BEYOND® FlexiPro™ Cheek Retractor (5 pack)-LBY-M015-L2022-12-23
00857848007605BEYOND® FlexiPro™ Cheek Retractor (single pack)-LBY-M016-L2022-12-23
00857848007674InPulse Dental LaserInPulse Touch 1002022-12-23
00857848007681BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MBY-M015-M2022-12-23
00857848007698BEYOND® FlexiPro™ Cheek Retractor (single pack)-MBY-M016-M2022-12-23
00857848007704BEYOND® FlexiPro™ Cheek Retractor (5 pack)-MixedBY-M015-MIX2022-12-23
00857848007711BEYOND® Polus® Advanced Ultra Whitening AcceleratorPLS-868UL2022-12-23
00857848007728BEYOND® II Ultra Whitening AcceleratorBE-818UL2022-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161302694Insti-Dam® - Latex-Free Rubber Dam - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161302717Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You AGEIE2025-12-18
10686864060298HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060304HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060311HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060328HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060335HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060342HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060359HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060366HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060373HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060397HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060403HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
07630392910781HySolateDent4You AGEIE2024-07-11
07630392910972HySolateDent4You AGEIE2024-07-11
00630094043265Bioseal Inc.BIOSEALEIE2024-01-18
10732224005581Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005598Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005604Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005611Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005628Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005635Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005642Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20