FDA.reportPublic FDA data

Henry Schein Essentials

Primary DI
H65811272821
Brand
Henry Schein Essentials
Company
HENRY SCHEIN, INC.
Model
1127282
Catalog number
1127282
Device description
Essentials Dental Amalgam Alloy 2 Spill Regular Set 50 jar
Published
2016-09-24
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
EJJAlloy, amalgam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJJAlloy, AmalgamDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821222000GOLDSMITH & REVERE TENARY ALLOYGoldsmith & Revere, Inc.1982-05-24EJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65811272821PrimaryHIBCC0
H65811272828Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgamA dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight600Milligram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool well-ventilated place
Storage Environment Temperature-4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
29336472004747BENCO ADMIXSDI LIMITEDEJJ2026-02-17
29336472004754BENCO SPHERICALSDI LIMITEDEJJ2026-02-17
29336472004860BENCO ADMIXSDI LIMITEDEJJ2026-02-17
29336472004877BENCO SPHERICALSDI LIMITEDEJJ2026-02-17
D662070830158PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070830166PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070830273PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070830281PD ADMIXSDI LIMITEDEJJ2026-02-17
D662070900258PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900266PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900373PD SPHERICALSDI LIMITEDEJJ2026-02-17
D662070900381PD SPHERICALSDI LIMITEDEJJ2026-02-17
09336472002091LOJIC+SDI LIMITEDEJJ2025-01-15
09336472001452LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001476LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001513LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001551LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001599LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001643LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001674LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001704LOJIC+SDI LIMITEDEJJ2025-01-09
09336472001742LOJIC +SDI LIMITEDEJJ2025-01-09
09336472001773LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002121LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002152LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002183LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002213LOJIC+SDI LIMITEDEJJ2025-01-09
09336472002275LOJIC+SDI LIMITEDEJJ2025-01-09
09336472000257PERMITESDI LIMITEDEJJ2025-01-08
09336472000288PERMITESDI LIMITEDEJJ2025-01-08