Dental Device Guide
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Manufacturer registered with FDA

Karl Klappenecker GmbH & Co. KG

TUTTLINGEN, Germany. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator8010453Contract manufacturer
Device types listed
1
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
44 registrations outside the US
Establishments
1Germany

Registered in 4 markets

Where regulators' registries name Karl Klappenecker GmbH & Co. KG as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedSouth Korea: 2 registrationsBrazil: 1 registrationsColombia: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerKarl Klappenecker GmbH & Co. KG1 device types—Below
South KoreaMFDSManufacturerKarl Klappenecker GmbH & Co. KG22012–2024Pure Global AI
BrazilANVISAManufacturerKARL KLAPPENECKER GMBH & CO. KG12011–2011Pure Global AI
ColombiaINVIMAManufacturerKARL KLAPPENECKER GMBH & CO. KG1—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Karl Klappenecker GmbH & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Surgical Bone ChiselEML · Class 1Dental hand instrumentsMaker—2014

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
KARL KLAPPENECKER GMBH & CO. KGFDA reg. 9611281TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 8010453). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.