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Device Explorer · FDA GUDID · GMDN 47971

Dental bone void filling material, synthetic

A bioabsorbable device made of synthetic material implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically made of ceramics (e.g., tricalcium

US‑registered devices172in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription90%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Collagen Matrix, Inc.4627%
Novabone Products, Llc3319%
Curasan Ag2615%
Gc America Inc.148%
Augma Biomaterials Ltd116%
Bicon, Llc85%
Degradable Solutions Ag63%
Institut Straumann Ag63%

Top labelers

CompanyDevicesShare
Collagen Matrix, Inc.4627%
Novabone Products, Llc3319%
Curasan Ag2615%
Gc America Inc.148%
Augma Biomaterials Ltd116%
Bicon, Llc85%
Degradable Solutions Ag63%
Institut Straumann Ag63%
Benco Dental Supply Co.42%
Megagen Implant Co. Ltd42%
Datum Dental Ltd32%
Algoss Biotechnologies Gmbh32%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

OSSIX™ Bone3D Bond3D Bond+Bond ApatiteShefabone™IngeniOS HAIngeniOS ß-TCP Bioactiv Synthetic Bone ParticlesOsbone DentalCERASORB Bioactivealgisorb™Bio TCP Beta-Tricalcium Phosphate Porous GranuKarl Schumacher Composite PuttyNewport Biologics Bone Graft Putty Mineral CollaDyna-Bone PlugGibson Healthcare AlloplastPLENA PLUG

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
LYCBone Grafting Material, Synthetic190
NPMBone Grafting Material, Animal Source50
LYCBone grafting material, synthetic34
LPKBone Grafting Material, For Dental Bone Repair7
NPMBONE GRAFTING MATERIAL, ANIMAL SOURCE3

GMDN & GCC registration

  • GMDN code 47971 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 90% · OTC 6%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Milliliter) · 28Total Volume (Centiliter) · 10Weight (Gram) · 10Pore Size (Micrometer) · 4Height (Millimeter) · 3Length (Millimeter) · 3

Use these as the dimensions to specify in a tender line.

How many dental bone void filling material, synthetic products are registered in the US?

172 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental bone void filling material, synthetic", from 16 companies. The largest labeler is Collagen Matrix, Inc. with 27% of records.

Which FDA product codes apply?

LYC (Bone Grafting Material, Synthetic), NPM (Bone Grafting Material, Animal Source), LYC (Bone grafting material, synthetic), LPK (Bone Grafting Material, For Dental Bone Repair)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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