FDA.reportPublic FDA data

Troposphere

Primary DI
H65810011811
Brand
Troposphere
Company
HENRY SCHEIN, INC.
Model
1001181
Catalog number
1001181
Device description
Troposphere 1 Spil 400mg 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
K951865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951865000ULTRA SPHERICAL AMALGAM ALLOYGoldsmith & Revere, Inc.1995-05-25EJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H65810011811PrimaryHIBCC0
H65810011818Unit 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
Weight400Milligram

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
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
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

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