FDA.reportPublic FDA data

Quinelato

Primary DI
07899798204737
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.127.29
Catalog number
QD.127.29
Device description
Chisel mark depth 9mm strong curve
Published
2022-10-24
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
EMIFile, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899798204737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899798204737078997982047377899798204737

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
00348783010053Premier FilePREMIER DENTAL PRODUCTS COMPANYEMI2026-04-27
00840018672642Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-11
00840018663589Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018665514Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-02-04
00840018662476Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018662858Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00840018663220Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMI2026-01-29
00194613115968MSI Precision Specialty InstrumentsMed Saver, Inc.EMI2025-08-01
00190776405229MillenniumAvalign Technologies, Inc.EMI2025-07-14
00889813066874Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00889813066881Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEMI2025-02-12
00840306823619Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00840306823626Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EMI2025-01-17
00813677025135PDT, Inc.PDT, INC.EMI2024-08-12
06974456210761CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
86974456210767CICADAFoshan Cicada Dental Instrument Co., Ltd.EMI2024-08-10
00813677024558PDT, Inc.PDT, INC.EMI2024-07-03
00813677024497PDT, Inc.PDT, INC.EMI2024-06-27
00190776388911AvalignAvalign Technologies, Inc.EMI2024-05-15
00842517105638Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00842517105645Karl SchumacherKarl Schumacher Dental, LLCEMI2024-03-18
00888515225336BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225374BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
00888515225497BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.EMI2024-02-28
08800075612892OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612908OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-27
08800075612878OSUNG MNDOSUNG MND Co., Ltd.EMI2024-02-19
D955BFS3201Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX1101Paul BandittTerlain Enterprises, Inc.EMI2023-12-11
D955BFX12C1Paul BandittTerlain Enterprises, Inc.EMI2023-12-11