FDA.reportPublic FDA data

Porcelain Repair

Primary DI
00883205044990
Brand
Porcelain Repair
Company
ULTRADENT PRODUCTS, INC.
Model
1108
Catalog number
1108
Device description
Porcelain Repair Kit
Published
2026-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205044990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205044990008832050449908832050449900883205044990

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-etching solutionAn acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205004550ViscoStat ClearS646S6462018-04-28
00883205103192ViscoStat Clear641064102018-04-28
00883205103208ViscoStat Clear640964092018-04-28
00883205106889ViscoStat Clear640764072018-04-28
00883205106896ViscoStat Clear640864082018-04-28
00883205045775ClearTemp LC351835182026-04-28
00883205045782ClearTemp LCS3518S35182026-04-28
00883205045805Universal Dentin Sealant2662662026-04-28
00883205045904UltraSealS3529S35292026-04-28
00883205045911Peak Universal BondS4554S45542026-04-28
00883205045928Peak Universal BondS4551S45512026-04-28
00883205045003Porcelain Etch4054052026-03-28
00883205045010UltraSeal XT353235322026-03-28
00883205045027UltraSeal XT353335332026-03-28
00883205045034Peak Universal Bond454145412026-03-28
00883205045041Peak Universal Bond454245422026-03-28
00883205045058Peak Universal Bond455145512026-03-28
00883205045720Porcelain Etch101910192026-03-28
00883205042835Opalustre5545542026-03-10
00883205042590PermaShade LC522752272026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EYET38800000K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET388000010K2 MyStains Structure SetYeti Dentalprodukte GmbHEIH2026-05-20
EYET38800230K2 MyStains ST-S13, uni red, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38800240K2 MyStains ST-S14, uni gingiva, 2g.Yeti Dentalprodukte GmbHEIH2026-05-20
EYET38780110K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780120K2 Li-Press-Pellets (HT-Hoch Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780210K2 Li-Press-Pellets (HT-Hoch Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780310K2 Li-Press-Pellets (HT-Hoch Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780320K2 Li-Press-Pellets (HT-Hoch Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780330K2 Li-Press-Pellets (HT-Hoch Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780340K2 Li-Press-Pellets (HT-Hoch Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781010K2 Li-Press-Pellets (LT-Low Transluzent) A1, 5X3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781020K2 Li-Press-Pellets (LT-Low Transluzent) A2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781030K2 Li-Press-Pellets (LT-Low Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781110K2 Li-Press-Pellets (LT-Low Transluzent) B1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781120K2 Li-Press-Pellets (LT-Low Transluzent) B2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781210K2 Li-Press-Pellets (LT-Low Transluzent) C1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781310K2 Li-Press-Pellets (LT-Low Transluzent) BL1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781320K2 Li-Press-Pellets (LT-Low Transluzent) BL2, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781330K2 Li-Press-Pellets (LT-Low Transluzent) BL3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38781340K2 Li-Press-Pellets (LT-Low Transluzent) BL4, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38782010K2 Li-Press-Pellets (medium-opak) MO1, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-11
EYET38780010K2 Li Press-Pellets HT-A1Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780020K2 Li Press-Pellets HT-A2Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38780030K2 Li-Press-Pellets (HT-Hoch Transluzent) A3, 5x3g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38801100K2 MyStains Structure Body dark, SM-B-D, 2g.Yeti Dentalprodukte GmbHEIH2026-05-07
EYET38760020K2 Li-Mamelon, MM-HO (HONEY), 20g.Yeti Dentalprodukte GmbHEIH2026-05-05
EYET38626150K2-HF OPAQUE DENTIN, OD-D3, 50g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38750060K2 Li-Clear, CL, 20g.Yeti Dentalprodukte GmbHEIH2026-05-04
EYET38760010K2 Li-Mamelon, MM-OR (ORANGE), 20g.Yeti Dentalprodukte GmbHEIH2026-05-04