FDA.reportPublic FDA data

Quinelato

Primary DI
07898506811939
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.401.21
Catalog number
QD.401.21
Device description
Apical elevator 301
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
EMJElevator, Surgical, Dental
EMLChisel, Bone, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506811939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506811939078985068119397898506811939

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. 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
00850083275549Intrace USAPILOTIS TECH LLCEMJ2026-07-03
00810189451216Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451223Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451230Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451247Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451254Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451261Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451278Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451285Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451292Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451308Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451315Surgical DesignSurgical Design, Inc.EMJ2026-06-06
ESAM14446251STOMA®Storz am Mark GmbHEMJ2025-04-30
ESAM14434001STOMA®Storz am Mark GmbHEMJ2024-03-14
ESAM14421251STOMA®Storz am Mark GmbHEMJ2023-04-24
ESAM4425081STOMA®Storz am Mark GmbHEMJ2023-04-24
ESAM4425101STOMA®Storz am Mark GmbHEMJ2023-04-24
ESAM4426031STOMA®Storz am Mark GmbHEMJ2023-04-24
ESAM4426051STOMA®Storz am Mark GmbHEMJ2023-04-24
07898506811496QuinelatoSchobell 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
07898506811854QuinelatoSchobell Industrial LtdaEMJ2022-12-08
07898506812158QuinelatoSchobell Industrial LtdaEMJ2022-12-08
ESAM14611101STOMA®Storz am Mark GmbHEMJ2022-11-07
ESAM1090401STOMA®Storz am Mark GmbHEMJ2020-11-09