FDA.reportPublic FDA data

Premier Cavity Prep

Primary DI
00348783008265
Brand
Premier Cavity Prep
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
1003189
Device description
CPI Hatchet-Black DE_BC 8/9
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
EKDInstrument, Cutting, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKDInstrument, Cutting, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783008265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783008265003487830082653487830082650348783008265

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
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783006919Premier Scalers056332026-05-06
00348783006971Premier Scalers056922026-05-06
00348783006988Premier Scalers056942026-05-06
00348783006995Premier Scalers056952026-05-06
00348783007251Premier Scalers90614002026-05-06
00348783007268Premier Scalers90614012026-05-06
00348783007275Premier Scalers90614022026-05-06
00348783007299Premier Scalers90614202026-05-06
00348783007329Premier Scalers90614232026-05-06
00348783007374Premier Scalers10046862026-05-06
00348783007398Premier Scalers10046882026-05-06
00348783007435Premier Scalers10046952026-05-06
00348783009422Premier Spreader10038662026-05-06
00348783009439Premier Spreader10038682026-05-06
00348783009446Premier Spreader10038692026-05-06
00348783009460Premier Spreader10038712026-05-06
00348783009484Premier Spreader10038732026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783008333Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008340Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008357Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783012248Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-02
00348783008272Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008289Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008319Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00840018635838NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635845NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635852NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635869NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635876NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635883NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635890NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635906NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635913NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635920NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635937NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635944NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635951NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635968NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635975NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635982NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018635999NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636002NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636019NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636026NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636033NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636040NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02
00840018636057NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCEKD2020-06-02