FDA.reportPublic FDA data

Quinelato

Primary DI
07898506843459
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.240.33
Catalog number
QD.240.33
Device description
Brunisher n.33
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506843459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506843459078985068434597898506843459

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
899060826
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899798207462QuinelatoQD.938.102025-02-27
07899798207721QuinelatoQD.310.032025-02-27
07899798208858QuinelatoQX.926.182025-02-27
07899798208865QuinelatoQX.923.162025-02-27
07899798208872QuinelatoQX.922.222025-02-27
07899798208216QuinelatoQN.950.15QN.950.152025-01-03
07899798208223QuinelatoQX.927.00QX.927.002025-01-03
07899798208230QuinelatoQX.927.01QX.927.012025-01-03
07899798208247QuinelatoQX.924.19QX.924.192025-01-03
07899798208254QuinelatoQX.925.24QX.925.242025-01-03
07899798208261QuinelatoQX.921.19QX.921.192025-01-03
07899798208278QuinelatoQX.920.19QX.920.192025-01-03
07898506850297QuinelatoQO.996.03QO.996.032023-07-05
07899798207509QuinelatoQD.721.15QD.721.152024-04-15
07899798207530QuinelatoQD.724.25QD.724.252024-04-15
07899798207547QuinelatoQD.725.30QD.725.302024-04-15
07899798207585QuinelatoQB.301.01QB.301.012024-04-15
07899798207592QuinelatoQB.302.01QB.302.012024-04-15
07899798207608QuinelatoQB.302.02QB.302.022024-04-15
07899798207615QuinelatoQB.301.02QB.301.022024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783009682Premier Composite InstrumentsPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-02
00348783009378Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009385Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009392Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009408Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783012293Premier ApplicatorsPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148102Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
00813677024978PDT, Inc.PDT, INC.EKJ2024-06-27
07898506811656QuinelatoSchobell Industrial LtdaEKJ2022-12-08
10889950004569HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004576HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004583HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004590HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004606HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004613HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004620HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004637HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004644HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004651HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12
10889950004668HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKJ2020-11-12