FDA.reportPublic FDA data

Wykalloy Capsules 2 Spill 500 count

Primary DI
00853383006073
Brand
Wykalloy Capsules 2 Spill 500 count
Company
Wykle Research, Inc
Model
73400
Published
2016-09-23
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
K002808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002808000ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOYNordiska Dental AB2000-10-31EJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853383006073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853383006073008533830060738533830060730853383006073

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
614557155
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853383006738Wykle Wedges Assorted Sizes 500 count7002016-09-23
00853383006745Wykle Wedges 11mm Natural Color 500 count7112016-09-23
00853383006752Wykle Wedges 13mm Yellow Color 500 count7132016-09-23
00853383006769Wykle Wedges 15mm Blue Color 500 count7152016-09-23
00853383006776Wykle Wedges 17mm Green Color 500 count7172016-09-23
00853383006011Original D Capsules 1 Spill Fast Set 50 count61143-032016-09-23
00853383006158Original D Tablets Fast Set 10 oz174-102016-09-23
00853383006202Original D Capsules 2 Spill Fast Set 100 count61240-032016-09-23
00853383006035Wykalloy Capsules 1 Spill 50 count730002016-09-23
00853383006042Wykalloy Capsules 2 Spill 50 count731002016-09-23
00853383006059Wykalloy Capsules 3 Spill 50 count732002016-09-23
00853383006066Wykalloy Capsules 1 Spill 500 count733002016-09-23
00853383006417Wykalloy amalgam sample pack759012016-12-14
00853383006523ANA 70 Powder 30g11100002018-04-13
00853383006547ANA 70 Powder 250g11102002018-04-13
00853383006554ANA 70 Duett 20011161002018-04-13
00853383006578ANA 70 Powder 500g11103002018-04-13
00853383006585ANA 70 Duett 5011181002018-04-13
00853383006608ANA 70 Duett 40011160002018-04-13
00853383006615ANA 2000 Powder 30g11700002018-04-13

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