FDA.reportPublic FDA data

Schobell

Primary DI
07899798203587
Brand
Schobell
Company
Schobell Industrial Ltda
Model
QD.261.00
Catalog number
QD.261.00
Device description
Turvey Maxillary Palatal Expander
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
EKFInstrument, Contouring, Matrix, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKFInstrument, Contouring, Matrix, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899798203587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899798203587078997982035877899798203587

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. 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
07897990399091UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990399213UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990399220UNIMATRIX STDV DENTAL LTDAEKF2026-02-18
07897990301919METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990301940METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990306297METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990306303METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990308611METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990308628METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-03-04
07897990301636PREMOLAR MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301643MOLAR MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301650DECIDUOUS MATRICESTDV DENTAL LTDAEKF2025-02-28
07897990301681METALLIC MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301698METALLIC MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301797UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301803UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301810UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301827UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301841UNIMATRIX PLIERTDV DENTAL LTDAEKF2025-02-28
07897990301872TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301889TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301896TOFFLEMIRE MATRIXTDV DENTAL LTDAEKF2025-02-28
07897990301902POLYESTER MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990301926METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990301933METALLIC MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28
07897990306662UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306679UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306686UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990306693UNIMATRIXTDV DENTAL LTDAEKF2025-02-28
07897990308581POLYESTER MATRIX STRIPTDV DENTAL LTDAEKF2025-02-28