FDA.reportPublic FDA data

Motion

Primary DI
04719871630303
Brand
Motion
Company
MOTION DENTAL EQUIPMENT CORPORATION
Model
GP-Cut
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04719871630303PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871630303047198716303034719871630303

GMDN Terms#

Term, Definition table
TermDefinition
Gutta percha cutterAn electrically-powered, hand-held device intended to be used to cut gutta percha pins inserted into the root canal of a tooth. It is typically a hand-held device with a thermoelectric wire (e.g., nickel-chromium alloy) at the distal end which delivers heat to cut the gutta percha. It might in addition provide the heat necessary to condense the gutta percha to seal the root canal.

Regulatory Flags#

DUNS number
656330482
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275662Intrace USAPILOTIS TECH LLCEKD2026-07-03
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
00348783008265Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008272Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008289Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
00348783008319Premier Cavity PrepPREMIER DENTAL PRODUCTS COMPANYEKD2026-04-01
07392532229480FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
07392532229497FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
07392532229503FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
07392532229510FRIADENT®Dentsply Implants Manufacturing GmbHEKD2022-11-10
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