Dental Device Guide
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Manufacturer registered with FDA

edelweiss dentistry products gmbh

Wolfurt, Austria. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10036346Contract manufacturerManufacturer1 clearance in five years
Device types listed
2
Brands and models
198
510(k) clearances
12024–2024
Markets registered in
528 registrations outside the US
Establishments
1Austria
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 5 markets

Where regulators' registries name edelweiss dentistry products gmbh as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedEuropean Union: 17 registrationsUnited Kingdom: 6 registrationsAustralia: 4 registrationsTaiwan: 1 registrations
RegisteredHome: AustriaOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufactureredelweiss dentistry products gmbh1 clearances2024–2024Below
European UnionEUDAMEDManufactureredelweiss dentistry products gmbh17—Pure Global AI
United KingdomMHRAManufactureredelweiss dentistry products GmbH6—Pure Global AI
AustraliaTGAManufacturerEdelweiss Dentistry Products GMBH42020–2023Pure Global AI
TaiwanTFDAManufacturerEDELWEISS DENTISTRY PRODUCTS GMBH12014–2014Pure 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 edelweiss dentistry products gmbh currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Resin Tooth Shade MaterialEBF · Class 2Dental compositesMaker
Ceramir CAD/CAM C-BLOCK A0Ceramir CAD/CAM C-BLOCK A1Ceramir CAD/CAM C-BLOCK A2Ceramir CAD/CAM C-BLOCK A3Ceramir CAD/CAM i-BLOCK (øL) A0Ceramir CAD/CAM i-BLOCK (øL) A1Ceramir CAD/CAM i-BLOCK (øL) A2Ceramir CAD/CAM i-BLOCK (øL) A3Ceramir CAD/CAM i-BLOCK (øL) Universal EnamelCeramir CAD/CAM i-BLOCK (øS) A0
25 more
Ceramir CAD/CAM i-BLOCK (øS) A1Ceramir CAD/CAM i-BLOCK (øS) A2Ceramir CAD/CAM i-BLOCK (øS) A3Ceramir CAD/CAM i-BLOCK (øS) Universal EnamelCeramir CAD/CAM T-BLOCK Universal Enameledelweiss CAD/CAM C-BLOCK A0 (10/12/16)edelweiss CAD/CAM C-BLOCK A0 (12/14/18)edelweiss CAD/CAM C-BLOCK A1 (10/12/16)edelweiss CAD/CAM C-BLOCK A1 (12/14/18)edelweiss CAD/CAM C-BLOCK A2 (10/12/16)edelweiss CAD/CAM C-BLOCK A2 (12/14/18)edelweiss CAD/CAM C-BLOCK A3 (10/12/16)edelweiss CAD/CAM C-BLOCK A3 (12/14/18)edelweiss CAD/CAM i-BLOCK (øL) A0edelweiss CAD/CAM i-BLOCK (øL) A1edelweiss CAD/CAM i-BLOCK (øL) A2edelweiss CAD/CAM i-BLOCK (øL) A3edelweiss CAD/CAM i-BLOCK (øL) Universal Enameledelweiss CAD/CAM i-BLOCK (øS) A0edelweiss CAD/CAM i-BLOCK (øS) A1edelweiss CAD/CAM i-BLOCK (øS) A2edelweiss CAD/CAM i-BLOCK (øS) A3edelweiss CAD/CAM i-BLOCK (øS) Universal Enameledelweiss CAD/CAM T-BLOCK Universal Enamel (10/12/16)edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18)
2011
Preformed CrownELZ · Class 1—Maker
Ceramir Pediatric Crown 51/E Size LCeramir Pediatric Crown 51/E Size MCeramir Pediatric Crown 51/E Size SCeramir Pediatric Crown 51/E Size XLCeramir Pediatric Crown 52/D Size LCeramir Pediatric Crown 52/D Size MCeramir Pediatric Crown 52/D Size SCeramir Pediatric Crown 52/D Size XLCeramir Pediatric Crown 53/C Size LCeramir Pediatric Crown 53/C Size M
153 more
Ceramir Pediatric Crown 53/C Size SCeramir Pediatric Crown 53/C Size XLCeramir Pediatric Crown 54/B Size LCeramir Pediatric Crown 54/B Size MCeramir Pediatric Crown 54/B Size SCeramir Pediatric Crown 54/B Size XLCeramir Pediatric Crown 55/A Size LCeramir Pediatric Crown 55/A Size MCeramir Pediatric Crown 55/A Size SCeramir Pediatric Crown 55/A Size XLCeramir Pediatric Crown 61/F Size LCeramir Pediatric Crown 61/F Size MCeramir Pediatric Crown 61/F Size SCeramir Pediatric Crown 61/F Size XLCeramir Pediatric Crown 62/G Size LCeramir Pediatric Crown 62/G Size MCeramir Pediatric Crown 62/G Size SCeramir Pediatric Crown 62/G Size XLCeramir Pediatric Crown 63/H Size LCeramir Pediatric Crown 63/H Size MCeramir Pediatric Crown 63/H Size SCeramir Pediatric Crown 63/H Size XLCeramir Pediatric Crown 64/I Size LCeramir Pediatric Crown 64/I Size MCeramir Pediatric Crown 64/I Size SCeramir Pediatric Crown 64/I Size XLCeramir Pediatric Crown 65/J Size LCeramir Pediatric Crown 65/J Size MCeramir Pediatric Crown 65/J Size SCeramir Pediatric Crown 65/J Size XLCeramir Pediatric Crown 71/O Size LCeramir Pediatric Crown 71/O Size MCeramir Pediatric Crown 71/O Size SCeramir Pediatric Crown 71/O Size XLCeramir Pediatric Crown 72/N Size LCeramir Pediatric Crown 72/N Size MCeramir Pediatric Crown 72/N Size SCeramir Pediatric Crown 72/N Size XLCeramir Pediatric Crown 73/M Size LCeramir Pediatric Crown 73/M Size MCeramir Pediatric Crown 73/M Size SCeramir Pediatric Crown 73/M Size XLCeramir Pediatric Crown 74/L Size LCeramir Pediatric Crown 74/L Size MCeramir Pediatric Crown 74/L Size SCeramir Pediatric Crown 74/L Size XLCeramir Pediatric Crown 75/K Size LCeramir Pediatric Crown 75/K Size MCeramir Pediatric Crown 75/K Size SCeramir Pediatric Crown 75/K Size XLCeramir Pediatric Crown 81/P Size LCeramir Pediatric Crown 81/P Size MCeramir Pediatric Crown 81/P Size SCeramir Pediatric Crown 81/P Size XLCeramir Pediatric Crown 82/Q Size LCeramir Pediatric Crown 82/Q Size MCeramir Pediatric Crown 82/Q Size SCeramir Pediatric Crown 82/Q Size XLCeramir Pediatric Crown 83/R Size LCeramir Pediatric Crown 83/R Size MCeramir Pediatric Crown 83/R Size SCeramir Pediatric Crown 83/R Size XLCeramir Pediatric Crown 84/S Size LCeramir Pediatric Crown 84/S Size MCeramir Pediatric Crown 84/S Size SCeramir Pediatric Crown 84/S Size XLCeramir Pediatric Crown 85/T Size LCeramir Pediatric Crown 85/T Size MCeramir Pediatric Crown 85/T Size SCeramir Pediatric Crown 85/T Size XLCeramir Pediatric Crown Start Kit CompleteCeramir Pediatric Crown Start Kit Smalledelweiss Pedatric Crown 85/T Size XLedelweiss Pediatric Crown 51/E Size Ledelweiss Pediatric Crown 51/E Size Medelweiss Pediatric Crown 51/E Size Sedelweiss Pediatric Crown 51/E Size XLedelweiss Pediatric Crown 52/D Size Ledelweiss Pediatric Crown 52/D Size Medelweiss Pediatric Crown 52/D Size Sedelweiss Pediatric Crown 52/D Size XLedelweiss Pediatric Crown 53/C Size Ledelweiss Pediatric Crown 53/C Size Medelweiss Pediatric Crown 53/C Size Sedelweiss Pediatric Crown 53/C Size XLedelweiss Pediatric Crown 54/B Size Ledelweiss Pediatric Crown 54/B Size Medelweiss Pediatric Crown 54/B Size Sedelweiss Pediatric Crown 54/B Size XLedelweiss Pediatric Crown 55/A Size Ledelweiss Pediatric Crown 55/A Size Medelweiss Pediatric Crown 55/A Size Sedelweiss Pediatric Crown 55/A Size XLedelweiss Pediatric Crown 61/F Size Ledelweiss Pediatric Crown 61/F Size Medelweiss Pediatric Crown 61/F Size Sedelweiss Pediatric Crown 61/F Size XLedelweiss Pediatric Crown 62/G Size Ledelweiss Pediatric Crown 62/G Size Medelweiss Pediatric Crown 62/G Size Sedelweiss Pediatric Crown 62/G Size XLedelweiss Pediatric Crown 63/H Size Ledelweiss Pediatric Crown 63/H Size Medelweiss Pediatric Crown 63/H Size Sedelweiss Pediatric Crown 63/H Size XLedelweiss Pediatric Crown 64/I Size Ledelweiss Pediatric Crown 64/I Size Medelweiss Pediatric Crown 64/I Size Sedelweiss Pediatric Crown 64/I Size XLedelweiss Pediatric Crown 65/J Size Ledelweiss Pediatric Crown 65/J Size Medelweiss Pediatric Crown 65/J Size Sedelweiss Pediatric Crown 65/J Size XLedelweiss Pediatric Crown 71/O Size Ledelweiss Pediatric Crown 71/O Size Medelweiss Pediatric Crown 71/O Size Sedelweiss Pediatric Crown 71/O Size XLedelweiss Pediatric Crown 72/N Size Ledelweiss Pediatric Crown 72/N Size Medelweiss Pediatric Crown 72/N Size Sedelweiss Pediatric Crown 72/N Size XLedelweiss Pediatric Crown 73/M Size Ledelweiss Pediatric Crown 73/M Size Medelweiss Pediatric Crown 73/M Size Sedelweiss Pediatric Crown 73/M Size XLedelweiss Pediatric Crown 74/L Size Ledelweiss Pediatric Crown 74/L Size Medelweiss Pediatric Crown 74/L Size Sedelweiss Pediatric Crown 74/L Size XLedelweiss Pediatric Crown 75/K Size Ledelweiss Pediatric Crown 75/K Size Medelweiss Pediatric Crown 75/K Size Sedelweiss Pediatric Crown 75/K Size XLedelweiss Pediatric Crown 81/P Size Ledelweiss Pediatric Crown 81/P Size Medelweiss Pediatric Crown 81/P Size Sedelweiss Pediatric Crown 81/P Size XLedelweiss Pediatric Crown 82/Q Size Ledelweiss Pediatric Crown 82/Q Size Medelweiss Pediatric Crown 82/Q Size S
2018

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

510(k) clearances

Clearances on which FDA names edelweiss dentistry products gmbh as the applicant.

Decided510(k)DeviceDevice type
18 Oct 2024K241131edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCKEBF Resin Tooth Shade Material

Some of these clearances are listed with FDA today by another company: Directa AB (1), Kettenbach GmbH & Co. KG (1).

Registered establishments

EstablishmentLocationWhat it does
EDELWEISS DENTISTRY PRODUCTS GMBHFDA reg. 3009117991Wolfurt Vorarlberg, AustriaContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10036346). 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.