FDA.reportPublic FDA data

Quinelato

Primary DI
07898506852499
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.130.05
Catalog number
QD.130.05
Device description
Wedelstaed 5/6 Chisel
Published
2022-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506852499PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506852499078985068524997898506852499

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
899060826
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
07899798207622QuinelatoQB.301.03QB.301.032024-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783006858Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006865Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006872Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006889Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006896Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006902Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006926Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006933Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006940Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006957Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783006964Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007282Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007305Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007312Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007336Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007343Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007350Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007367Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007381Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007404Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007411Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007428Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007442Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
00348783007459Premier ScalersPREMIER DENTAL PRODUCTS COMPANYEMN2026-03-17
G149TBS204S01TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSAS1208TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSG171800TBS DentalACME ENTERPRISE.EMN2026-03-02
G149TBSLADY02TBS DentalACME ENTERPRISE.EMN2026-03-02
10889950145590Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-30
10889950145569Hu_FriedyHU-FRIEDY MFG. CO., LLCEMN2026-01-22