Schlumbohm GmbH & Co. KG

Address:Klein Floyen 8-10,Brokstedt Schleswig-Holstein,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

Handpiece, Direct Drive, Ac-Powered (EKX) (6) Locator, Root Apex (LQY) (4) Plugger, Root Canal, Endodontic (EKR) (1)

Premarket Exempt

Clear

EndoPilot Motor - 04260482990084 Catalog Number : 109 0112

Device Description : EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

EndoPilot contra-angle - 04260482990091 Catalog Number : 109 0126

Device Description : EndoPilot contra-anglefor apexlocationfull isolatedtransmission 1:1with ISO-E standard

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

EndoPilot D-Pack - 04260482990190 Catalog Number : 109 0151

Device Description : Downpack (D-Pack) handpiece for EndoPilot

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKR

Prescription Use : Yes

Device Count : 1

EndoPilot apex cable set - 04260482990282 Catalog Number : 109 2311

Device Description : Apex-cable-Setfor Endopilot, consist of:1x measuring cable with plug;1x lip clip

Device Class : U

Duns Number: 343831731

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

EndoPilot Lip-clip - 04260482990305 Catalog Number : 109 2314

Device Description : Lip-clipfor EndoPilot apex-cable

Device Class : U

Duns Number: 343831731

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

EndoPilot Apex measuring cable with plug - 04260482990589 Catalog Number : 109 2312

Device Description : Apex measuring cable with plug

Device Class : U

Duns Number: 343831731

Premarket Exempt : No

Product Code : LQY

Prescription Use : Yes

Device Count : 1

EndoPilot wireless-footswitch, twin - 04260482990596 Catalog Number : 109 2351

Device Description : Wireless-Footswitchfor EndoPilot, twin

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

EndoPIlot wireless-footswitch, single - 04260482990602 Catalog Number : 109 2361

Device Description : EndoPIlot wireless-footswitch, single

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

EndoPilot Control Box, Komet - 04260482990763 Catalog Number : 110 2011

Device Description : EndoPilot² Control Box, Komet

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKX, LQY

Prescription Use : Yes

Device Count : 1

EndoPilot power supply - 04260482990787 Catalog Number : 110 2203

Device Description : AC/DC power supply for EndoPilot²

Device Class : 1

Duns Number: 343831731

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

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