FDA.reportPublic FDA data

Original D Capsules 1 Spill Extra Fast Set 100 caps

Primary DI
00853383006097
Brand
Original D Capsules 1 Spill Extra Fast Set 100 caps
Company
Wykle Research, Inc
Model
61130-03
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIVDental Amalgam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIVDental AmalgamDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853383006097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853383006097008533830060978533830060970853383006097

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
Premarket exempt
true
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
00853383006073Wykalloy Capsules 2 Spill 500 count734002016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07701126651000Nu Alloy Caps. Jar X 50 - 2 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-24
07701126651024Nu Alloy Active Caps. Jar X 50 - 1 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-24
07701126651048Nu Alloy Dp Active Caps. Jar X 50 - 3 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-24
07701126650959Nu Alloy dp Active Caps. Jar X 500 - 2 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-23
07701126650966Nu Alloy dp Active Caps. Jar X 500 - 1 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-23
07701126650973Nu Alloy Caps. Jar X 500 - 1 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-23
07701126650980Nu Alloy dp Caps. Jar X 500 - 2 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-23
07701126650997Nu Alloy Caps. Jar X 50 - 1 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-23
07701126651031Nu Alloy Dp Active Caps. Jar X 50 - 2 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-05-23
07701126650898Nu Alloy dp40 Caps. Jar X 500 - 1 SpillPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AOIV2017-02-01
00853383006448Original D 3 spill amalgam regular set sample packWykle Research, IncOIV2016-12-14
00853383006479Original D 3 spill amalgam fast set sample packWykle Research, IncOIV2016-12-14
00853383006530Original D 2 spill amalgam regular set sample packWykle Research, IncOIV2016-12-14
00853383006561Original D 2 spill amalgam fast set sample packWykle Research, IncOIV2016-12-14
00853383006592Original D 2 spill ex fast set amalgam sample packWykle Research, IncOIV2016-12-14
00853383006653Original D 1 spill amalgam regular set sample packWykle Research, IncOIV2016-12-14
00853383006684Original D 1 spill amalgam fast set sample packWykle Research, IncOIV2016-12-14
00853383006714Original D 1 spill amalgam exfast set sample packWykle Research, IncOIV2016-12-14
00853383006943Original D Ex Fast JarWykle Research, IncOIV2016-11-28
00853383006950Original D Powder Ex Fast Set 10 ozWykle Research, IncOIV2016-11-28
00853383006967Original D Powder Ex Fast Set 5 ozWykle Research, IncOIV2016-11-28
00853383006929Original D Powder 5 min JarWykle Research, IncOIV2016-11-11
00853383006936Original D Powder 4 min jarWykle Research, IncOIV2016-11-11
00853383006004Original D Capsules 1 Spill Regular Set 50 countWykle Research, IncOIV2016-09-23
00853383006011Original D Capsules 1 Spill Fast Set 50 countWykle Research, IncOIV2016-09-23
00853383006028Original D Capsules 1 Spill Extra Fast Set 50 countWykle Research, IncOIV2016-09-23
00853383006103Original D Capsules 1 Spill Extra Fast 500 countWykle Research, IncOIV2016-09-23
00853383006110Original D Capsules 2 Spill Extra Fast Set 50 countWykle Research, IncOIV2016-09-23
00853383006127Original D Capsules 2 Spill Extra Fast Set 100 countWykle Research, IncOIV2016-09-23
00853383006134Original D Capsules 2 Spill Extra Fast Set 500 countWykle Research, IncOIV2016-09-23