FDA.reportPublic FDA data

Henry Schein

Primary DI
20304040132887
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702070
Catalog number
5702070
Device description
Natural Elegance Pit & Fissure Sealant BPA Free
Published
2020-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190998000BA Pit & Fissure SealantApex Dental Materials, Inc.2019-11-08EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20304040132887PackageGS130In Commercial Distribution
10304040132880PrimaryGS10
00304040132883Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030404013288720304040132887
1030404013288010304040132880
00304040132883003040401328833040401328830304040132883

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
4
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040058084Henry Schein112673611267362019-11-26
10304040200589Henry Schein570609457060942026-10-06
10304040193843Henry Schein570560657056062026-10-05
10304040193850Henry Schein570560757056072026-10-05
10304040193867Henry Schein570560857056082026-10-05
10304040193874Henry Schein570560957056092026-10-05
10304040193881Henry Schein570561057056102026-10-05
10304040193898Henry Schein570561157056112026-10-05
10304040194109Henry Schein570562257056222026-10-05
10304040194116Henry Schein570562357056232026-10-05
10304040194208Henry Schein570569757056972026-10-05
10304040194215Henry Schein570569857056982026-10-05
10304040194222Henry Schein570569957056992026-10-05
10304040194239Henry Schein570570057057002026-10-05
10304040194246Henry Schein570570157057012026-10-05
10304040194253Henry Schein570570257057022026-10-05
10304040194260Henry Schein570570357057032026-10-05
10304040194277Henry Schein570570457057042026-10-05
10304040194284Henry Schein570570557057052026-10-05
10304040194291Henry Schein570570657057062026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00766054003045BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003052BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003069BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003076BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003083BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003090BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003106BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003113BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003120BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
00766054003137BelixaESSENTIAL DENTAL SYSTEMS, INC.EBF2026-11-01
EDMG2228071Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228081Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228091Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228101Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228121Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228131Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228141Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228151Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228161Ecosite Elements Highlight Refill IncisalDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228171Ecosite Elements Highlight Refill OA2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228181Ecosite Elements Highlight Refill WhiteDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228191Ecosite Elements Highlight Refill BrownDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228201Ecosite Elements Pure Refill B1DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228211Ecosite Elements Pure Refill A2DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228221Ecosite Elements Pure Refill A3DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228231Ecosite Elements Pure Refill A3.5DMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228251Ecosite Elements Layer Refill EBDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228261Ecosite Elements Layer Refill ELDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228271Ecosite Elements Layer Refill EMDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30
EDMG2228281Ecosite Elements Layer Refill EDDMG Chemisch-Pharmazeutische Fabrik GmbHEBF2026-10-30