Manufacturer registered with FDA

Musculoskeletal Transplant Foundation

Edison, NJ, United States. Lists 1 dental device type with FDA across 3 registered establishments, and holds 2 510(k) clearances as applicant.

FDA owner/operator9032400Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
22005–2009
Markets registered in
1059 registrations outside the US
Establishments
3United States
2005: 12009: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 10 markets

Where regulators' registries name Musculoskeletal Transplant Foundation as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedPeru: 22 registrationsCanada: 13 registrationsColombia: 12 registrationsSaudi Arabia: 4 registrationsIsrael: 3 registrationsTaiwan: 2 registrationsHong Kong: 1 registrationsSouth Korea: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerMusculoskeletal Transplant Foundation2 clearances2005–2009Below
PeruDIGEMIDManufacturerMUSCULOSKELETAL TRANSPLANT FOUNDATION222016–2025Pure Global AI
CanadaHealth CanadaRegistration holderMUSCULOSKELETAL TRANSPLANT FOUNDATION132001–2018Pure Global AI
ColombiaINVIMAManufacturerMUSCULOSKELETAL TRANSPLANT FOUNDATION12—Pure Global AI
Saudi ArabiaSFDAManufacturerMUSCULOSKELETAL TRANSPLANT FOUNDATION4—Pure Global AI
IsraelAMARManufacturerMusculoskeletal Transplant Foundation3—Pure Global AI
TaiwanTFDAManufacturerMUSCULOSKELETAL TRANSPLANT FOUNDATIONMusculoskeletal Transplant Foundation22018–2019Pure Global AI
Hong KongMDDManufacturerMusculoskeletal Transplant Foundation12025–2025Pure Global AI
South KoreaMFDSManufacturerMusculoskeletal Transplant Foundation12006–2006Pure Global AI
United KingdomMHRAManufacturerMusculoskeletal Transplant Foundation1—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 Musculoskeletal Transplant Foundation currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Human Source Bone Grafting MaterialNUN · Class 2Bone grafts & membranesMaker
DBX Dental
2013

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 Musculoskeletal Transplant Foundation as the applicant, including filings under its other names.

Decided510(k)DeviceDevice type
2 Oct 2009K091217DBX DEMINERALIZED BONE MATRIX PUTTYNUN Human Source Bone Grafting Material
29 Apr 2005K040501DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIXNUN Human Source Bone Grafting Material

Registered establishments

EstablishmentLocationWhat it does
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsFDA reg. 3008812241Olyphant, PA, United StatesManufacturer
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsFDA reg. 1000307092JESSUP, PA, United StatesManufacturer
Musculoskeletal Transplant Foundation d/b/a/ MTF BiologicsFDA reg. 2249062EDISON, NJ, United StatesManufacturer

Other names on FDA records

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9032400). 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.