FDA.reportPublic FDA data

ViscoStat

Primary DI
00883205004529
Brand
ViscoStat
Company
ULTRADENT PRODUCTS, INC.
Model
1129-
Catalog number
1129-
Device description
UNIV UD Tissue Management Kit
Published
2018-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JESFLOSS, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205004529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205004529008832050045298832050045290883205004529

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction kitA collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

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
00883205044990Porcelain Repair110811082026-03-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00070942008822GUM® Expanding FlossSUNSTAR AMERICAS, INC.JES2026-05-01
00070942008952GUM® Professional Clean FlossSUNSTAR AMERICAS, INC.JES2026-04-30
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERSSUNSTAR AMERICAS, INC.JES2025-11-04
10371347019732Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10371347019749Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-06-25
10810063755567Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756182Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756199Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756656Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756663Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10304040189853Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189860Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189877Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
10304040189884Henry ScheinHENRY SCHEIN, INC.JES2025-01-30
00032251933462Family WellnessFamily Dollar StoresJES2024-05-03
00032251933486Family WellnessFamily Dollar StoresJES2024-05-03
00032251933493Family WellnessFamily Dollar StoresJES2024-05-03
00032251933523Family WellnessFamily Dollar StoresJES2024-05-03
00032251933479Family WellnessFamily Dollar StoresJES2024-04-09
00032251933509Family WellnessFamily Dollar StoresJES2024-04-09
00070942007153GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942007177GUM®SUNSTAR AMERICAS, INC.JES2024-04-05
00070942006590GUM®SUNSTAR AMERICAS, INC.JES2024-03-15
00070942006552GUM®SUNSTAR AMERICAS, INC.JES2024-03-14
00070942006576GUM®SUNSTAR AMERICAS, INC.JES2024-03-13
00070942006514GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006613GUM®SUNSTAR AMERICAS, INC.JES2024-03-12
00070942006606GUM®SUNSTAR AMERICAS, INC.JES2024-03-07
00070942006583GUM®SUNSTAR AMERICAS, INC.JES2024-03-05