Not currently registered with FDA under this name

Biocomposites, Ltd.

Keele, United Kingdom. Named as applicant on 3 dental 510(k) clearances between 2000 and 2008. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32000–2008
Markets registered in
17124 registrations outside the US
Establishments
0—
2000: 12005: 12008: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 17 markets

Where regulators' registries name Biocomposites, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesColombia: 33 registrationsCanada: 24 registrationsAustralia: 11 registrationsTaiwan: 10 registrationsUnited Kingdom: 8 registrationsSouth Korea: 7 registrationsCosta Rica: 5 registrationsSaudi Arabia: 5 registrationsBrazil: 4 registrationsEgypt: 4 registrationsIsrael: 4 registrationsHong Kong: 3 registrationsChina: 2 registrationsPeru: 2 registrationsEuropean Union: 1 registrationsSerbia: 1 registrations
RegisteredHome: United KingdomOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantBiocomposites, Ltd.3 clearances2000–2008Below
ColombiaINVIMARegistration holderBIOCOMPOSITES LIMITEDBIOCOMPOSITES LTD33—Pure Global AI
CanadaHealth CanadaRegistration holderBIOCOMPOSITES LTD.242003–2025Pure Global AI
AustraliaTGAManufacturerBiocomposites LtdBiocomposites GmbH112005–2022Pure Global AI
TaiwanTFDAManufacturerBIOCOMPOSITES LTD.Biocomposites Ltd.102006–2024Pure Global AI
United KingdomMHRAManufacturerBiocomposites LtdBiocomposites GmbH8—Pure Global AI
South KoreaMFDSManufacturerBiocomposites LimitedBiocomposites Ltd · BIOCOMPOSITES Limited · +172003–2012Pure Global AI
Costa RicaMinisterio de SaludManufacturerBIOCOMPOSITES LIMITEDBiocomposites Ltd · BIOCOMPOSITES LTD.5—Pure Global AI
Saudi ArabiaSFDAManufacturerBiocomposites Ltd5—Pure Global AI
BrazilANVISAManufacturerBIOCOMPOSITES LTD42013–2017Pure Global AI
EgyptEDAManufacturerBiocomposites Ltd,42023–2026Pure Global AI
IsraelAMARManufacturerBiocomposites LtdBiocomposites Ltd.4—Pure Global AI
Hong KongMDDManufacturerBiocomposites Ltd32023–2023Pure Global AI
ChinaNMPARegistration holder英国百赛公司Biocomposites Ltd2—Pure Global AI
PeruDIGEMIDManufacturerBIOCOMPOSITES LTD.22026–2026Pure Global AI
European UnionEUDAMEDManufacturerBiocomposites Ltd1—Pure Global AI
SerbiaALIMSManufacturerBiocomposites Ltd.12024–2024Pure 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

510(k) clearances

Clearances on which FDA names Biocomposites, Ltd. as the applicant.

Decided510(k)DeviceDevice type
5 Sep 2008K082383FORTOSS VITALLYC Synthetic Bone Grafting Material
26 Aug 2005K050170FORTOSS VITAL BONE GRAFT SUBSTITUTELYC Synthetic Bone Grafting Material
14 Jan 2000K993238FORTOSS-CEMALYC Synthetic Bone Grafting Material

Sources

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 of the most recent filing, which can be a US agent.