FDA.reportPublic FDA data

QUALA

Primary DI
D023Q480601
Brand
QUALA
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
Q48060
Catalog number
Q48060
Device description
QUALA WAX MINT SPOOL DENTAL FLOSS 200 YARDS 12BX 6BX/CS
Published
2018-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D023Q480603PackageHIBCC72In Commercial Distribution
D023Q480601PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental flossA string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
615-366-3230COMPLIANCE@NDC-INC.COM

Regulatory Flags#

DUNS number
009831413
Device count
1
Premarket exempt
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
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