Kohdent Roland Kohler Medizintechnik GmbH & Co. KG

Address:BODENSEEALLEE 14-16,STOCKACH Baden-Wurttemberg,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

CHISEL, OSTEOTOME, SURGICAL (EMM) (3) ELEVATOR, SURGICAL, DENTAL (EMJ) (2) PUNCH, BIOPSY, SURGICAL (EME) (2) ACCESSORIES, RETRACTOR, DENTAL (EIF) (1) FORCEPS, TOOTH EXTRACTOR, SURGICAL (EMG) (1) NEEDLE, DENTAL (DZM) (1)

Premarket Exempt

Yes

Clear

KOHDENT - 04251436933745 Catalog Number : 7464

Device Description : Rotary tissue punch, with centering pin 3,5 mm inner dia., red, for contra- Rotary tissue punch, with centering pin 3,5 mm inner dia., red, for contra- angled handpieces

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EME

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933752 Catalog Number : 7465

Device Description : Rotary tissue punch, with centering pin 4,3 mm inner dia., white, for contra- Rotary tissue punch, with centering pin 4,3 mm inner dia., white, for contra- angled handpieces

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EME

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933769 Catalog Number : 7667

Device Description : TC-needle holders Castro. TRINOVO curved 17,5cm - thick jaws

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : DZM

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933776 Catalog Number : 7891

Device Description : MINVALUX Set Luxating Instruments consisting of 9 instruments + MIDI Tray

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EMJ

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933783 Catalog Number : 7909

Device Description : Chisel KOIS TRINOVO handle 8.5 mm

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EMM

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933790 Catalog Number : 7989

Device Description : Osteotome, elastic blade, TRINOVO 21 cm, 8 mm, curved

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EMM

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933806 Catalog Number : 7990

Device Description : Osteotome, elastic blade, TRINOVO 21 cm, 10 mm, curved

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EMM

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933813 Catalog Number : 7999

Device Description : Root elevator WOODSON with Unique handle

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EMJ

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933820 Catalog Number : 8440

Device Description : Endo Retractor UCLA Dr. Han - version 2017 - 175 mm

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

KOHDENT - 04251436933837 Catalog Number : 1171-S

Device Description : Extracting Forceps American No.32A serrated

Device Class : 1

Duns Number: 324006097

Premarket Exempt : Yes

Product Code : EMG

Prescription Use : Yes

Device Count : 1

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