FDA.reportPublic FDA data

Quala

Primary DI
D023Q0550031
Brand
Quala
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
Q055003
Catalog number
Q055003
Device description
Quala Alloy Amalgam 1 Spill FS 500 Bulk
Published
2017-02-13
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
K820617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820617000DISPERSED PHASE ALLOYGoldsmith & Revere, Inc.1982-03-25EJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D023Q0550033PackageHIBCC4
D023Q0550031PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009831413
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M220P3010088Pro AdvantageP301008P3010082017-02-13
M220P3011058Pro AdvantageP301105P3011052017-02-13
M220P3011158Pro AdvantageP301115P3011152017-02-13
D023Q4000418QualaQ40004Q400042017-02-13
D023Q400042ML1QualaQ400042MLQ400042ML2017-04-25
D023Q400122ML19QualaQ400122MLQ400122ML2017-10-18
D023Q4003017QualaQ40030Q400302017-02-13
D23Q4001217QualaQ40012Q400122017-02-13
M2207250003Pro Advantage72000720002025-09-11
M220761002Pro Advantage76100761002025-09-11
M220762002Pro Advantage76200762002025-09-11
M220767000Pro Advantage76700767002025-09-11
M220768001Pro Advantage76800768002025-09-11
M220768011Pro Advantage76801768012025-09-11
M220769000Pro Advantage76900769002025-09-11
M220770001Pro Advantage77000770002025-09-11
M220771001Pro Advantage77100771002025-09-11
M220720005Pro Advantage72000720002025-09-11
M220761003Pro Advantage76100761002025-09-11
M220762003Pro Advantage76200762002025-09-11

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