FDA.reportPublic FDA data

Premier Cavity Prep

Primary DI
00348783008296
Brand
Premier Cavity Prep
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1003228
Device description
BLACK CUTTING INSTR 61/62
Published
2026-04-01
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
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783008296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783008296003487830082963487830082960348783008296

GMDN Terms#

Term, Definition table
TermDefinition
Margin finishing dental file/rasp, reusableA hand-held manual dental instrument that has various forms of fine ridged cutting surfaces at its working end(s) designed to smooth and shape a tooth, an approximate bone (e.g., alveolar) and/or a dental restoration (e.g., filling). It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275624Intrace USAPILOTIS TECH LLCEKC2026-07-03
00348783008500Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008517Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008524Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008531Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008548Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008555Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008562Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008579Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008609Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008616Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008623Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008647Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008661Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008685Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008692Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008708Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008715Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
07898506841585QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843282QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843299QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843305QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843763QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843770QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843787QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506851799QuinelatoSchobell Industrial LtdaEKC2022-12-08
10889950010065HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010089HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010096HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12