FDA.reportPublic FDA data

Quinelato

Primary DI
07898506811472
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.151.01
Catalog number
QD.151.01
Device description
Ochsenbein micro periodontal chisel n° 1
Published
2022-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIGRetractor, All Types
EMLChisel, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIGRetractor, All TypesDental1
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506811472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506811472078985068114727898506811472

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
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
08961104622197Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622203Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622210Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622227Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622234Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622241Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622258Cheek Retractor SmallMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622265Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622272Cheek RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
08961104622289Lip RetractorMELPEX BEAUTY INSTRUMENTSEIG2026-05-21
10304040196998Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197001Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
10304040197018Henry ScheinHENRY SCHEIN, INC.EIG2026-05-14
G149NP260020NPSACME ENTERPRISE.EIG2026-05-01
G149NPORR0NPSACME ENTERPRISE.EIG2026-05-01
ESAM4028011STOMA®Storz am Mark GmbHEIG2025-04-30
G586NS600073110Novo SurgicalNOVO SURGICAL, INC.EIG2024-02-22
G586NS600813210Novo SurgicalNOVO SURGICAL, INC.EIG2024-02-22
G586NS600984610Novo SurgicalNOVO SURGICAL, INC.EIG2024-02-22
07898506811496QuinelatoSchobell Industrial LtdaEML2023-01-10
07898506852963QuinelatoSchobell Industrial LtdaEML2023-01-10
07898506854714QuinelatoSchobell Industrial LtdaEML2023-01-10
07898506811304QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506816439QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506849697QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506850440QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506851768QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506852482QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506855483QuinelatoSchobell Industrial LtdaEML2023-01-09
07898506855490QuinelatoSchobell Industrial LtdaEML2023-01-09