FDA.reportPublic FDA data

Quinelato

Primary DI
07898506843466
Brand
Quinelato
Company
Schobell Industrial Ltda
Model
QD.220.01
Catalog number
QD.220.01
Device description
Paiva plugger n° 1
Published
2022-11-29
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
EIKCarver, Wax, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIKCarver, Wax, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898506843466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898506843466078985068434667898506843466

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic pluggerA hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. 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
08404535024906Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024937Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
08404535024968Brasseler USAPeter Brasseler Holdings, LLCEIK2026-03-23
00840018666016Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-09
00840018663671Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665293Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665439Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018665446Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-02-04
00840018663305Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-29
00840018661172Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00840018661301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIK2026-01-28
00813677024145PDT, Inc.PDT, INC.EIK2024-06-27
00813677024152PDT, Inc.PDT, INC.EIK2024-06-27
00813677024169PDT, Inc.PDT, INC.EIK2024-06-27
00813677024176PDT, Inc.PDT, INC.EIK2024-06-27
00813677024183PDT, Inc.PDT, INC.EIK2024-06-27
00310866002644GET SCULPTEDPASCAL COMPANY, INC.EIK2024-05-16
00842517119352Karl SchumacherKarl Schumacher Dental, LLCEIK2024-05-06
08800075626479OSUNG MNDOSUNG MND Co., Ltd.EIK2024-03-06
08800075626516OSUNG MNDOSUNG MND Co., Ltd.EIK2024-03-06
08800075626486OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626493OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626509OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
08800075626523OSUNG MNDOSUNG MND Co., Ltd.EIK2024-02-23
G1577046890PomeePOMEE CORPORATIONEIK2023-10-16
G1577132500PomeePOMEE CORPORATIONEIK2023-10-11
G1577132700PomeePOMEE CORPORATIONEIK2023-10-11
G1577132750PomeePOMEE CORPORATIONEIK2023-10-11
G1577132770PomeePOMEE CORPORATIONEIK2023-10-11
G1577133030PomeePOMEE CORPORATIONEIK2023-10-11