Dental Device Guide
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Manufacturer registered with FDA

Augma Biomaterials

Caesarea Southern Industrial Park, Israel. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10029027Manufacturer
Device types listed
1
Brands and models
3
510(k) clearances
22009–2013
Markets registered in
727 registrations outside the US
Establishments
1Israel
2009: 12013: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 7 markets

Where regulators' registries name Augma Biomaterials as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedEuropean Union: 14 registrationsIsrael: 7 registrationsAustralia: 3 registrationsColombia: 1 registrationsCosta Rica: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerAugma Biomaterials2 clearances2009–2013Below
European UnionEUDAMEDManufacturerAugma Biomaterials Ltd.14—Pure Global AI
IsraelAMARRegistration holderAugma Biomaterials Ltd.7—Pure Global AI
AustraliaTGAManufacturerAugma Biomaterials Ltd32024–2024Pure Global AI
ColombiaINVIMAManufacturerAUGMA BIOMATERIALS LTD.1—Pure Global AI
Costa RicaMinisterio de SaludManufacturerAUGMA BIOMATERIALS LTD.1—Pure Global AI
United KingdomMHRAManufacturerAugma Biomaterials Ltd1—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 Augma Biomaterials currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Synthetic Bone Grafting MaterialLYC · Class 2Bone grafts & membranesMaker
Bond Apatite3D Bond3D Bond+
2009

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 Augma Biomaterials as the applicant.

Decided510(k)DeviceDevice type
5 Dec 2013K121177BOND APATITELYC Synthetic Bone Grafting Material
17 Mar 2009K083858BOND BONELYC Synthetic Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
AUGMA BIOMATERIALSFDA reg. 3007490610Caesarea Southern Industrial Park Northern, IsraelManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10029027). 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.