FDA.reportPublic FDA data

Quala

Primary DI
D023200371B1
Brand
Quala
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
200-371-B
Catalog number
200-371-B
Device description
Quala Cover Film Blue 4X6
Published
2017-02-13
Public version status
Update
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
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960352000ALLRAP/SLIP-N-GRIPDental Disposables Intl., Inc.1996-02-21EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D023200371B1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, non-sterileA non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
6153663230compliance@ndc-inc.com

Regulatory Flags#

DUNS number
009831413
Device count
1
Lot or batch
true
Manufacturing date on label
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
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301280011WE-57 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301290011HE-43 T SD Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11