FDA.reportPublic FDA data

J&J Instruments

Primary DI
00817524021509
Brand
J&J Instruments
Company
J & J INSTRUMENTS INC
Model
04-603
Device description
CLEOID DISCOID #3/6 LARGE
Published
2019-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00817524021509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524021509008175240215098175240215090817524021509

GMDN Terms#

Term, Definition table
TermDefinition
Dental plastic restoration carverA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental plastic restorations, e.g., for cutting, scraping, paring, and smoothing finishes and fashioning patterns (non-patient-contact). It will typically be a double-ended metal instrument with a solid blunt blade/nib of various sizes and designs with a central handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
783328149
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00817524029963J&J Instruments03-50003-5002023-10-10
00817524029970J&J Instruments09-50009-5002023-10-10
00817524029956J&J Instruments18-604018-60402023-06-08
00817524026740J&J Instruments31-100031-10002023-03-01
00817524026757J&J Instruments31-101031-10102023-03-01
00817524026764J&J Instruments31-117031-11702023-03-01
00817524026771J&J Instruments31-118031-11802023-03-01
00817524026788J&J Instruments31-119031-11902023-03-01
00817524026795J&J Instruments33-200033-20002023-03-01
00817524026801J&J Instruments33-303033-30302023-03-01
00817524026818J&J Instruments33-306533-30652023-03-01
00817524026825J&J Instruments33-410033-41002023-03-01
00817524026832J&J Instruments33-415033-41502023-03-01
00817524026849J&J Instruments33-523033-52302023-03-01
00817524026856J&J Instruments33-526033-52602023-03-01
00817524026863J&J Instruments33-615033-61502023-03-01
00817524027532J&J Instruments37-500537-50052023-03-01
00817524027549J&J Instruments37-301037-30102023-03-01
00817524027556J&J Instruments37-302037-30202023-03-01
00817524027563J&J Instruments37-303037-30302023-03-01

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