Manufacturer registered with FDA

Cytophil, Inc

East Troy, WI, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10025827Manufacturer
Device types listed
1
Brands and models
0
510(k) clearances
22009–2010
Markets registered in
613 registrations outside the US
Establishments
1United States
2009: 12010: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 6 markets

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

All markets
United States: 1 device types listedColombia: 6 registrationsUnited Kingdom: 3 registrationsSaudi Arabia: 2 registrationsIsrael: 1 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerCytophil, Inc2 clearances2009–2010Below
ColombiaINVIMARegistration holderCYTOPHIL, INC6—Pure Global AI
United KingdomMHRAManufacturerCytophil, Inc.3—Pure Global AI
Saudi ArabiaSFDAManufacturerCytophil, IncCytophil, Inc.2—Pure Global AI
IsraelAMARManufacturerCytophil, Inc.1—Pure Global AI
PeruDIGEMIDManufacturerCYTOPHIL, INC12013–2013Pure 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 Cytophil, Inc 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—2011

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 Cytophil, Inc as the applicant.

Decided510(k)DeviceDevice type
22 Apr 2010K093871PERIOPHIL B-TCPLYC Synthetic Bone Grafting Material
18 Dec 2009K092788PERIOPHIL BIPHASICLYC Synthetic Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
Cytophil, IncFDA reg. 3007225376East Troy, WI, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10025827). 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.