Home GUDID 07290015477253 OSSIX™ Bone
Primary DI 07290015477253
Brand OSSIX™ Bone
Company DATUM DENTAL LTD
Model 0.500 cc
Catalog number OXB0500
Device description OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
Published 2017-08-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NPM Bone Grafting Material, Animal Source
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NPM Bone Grafting Material, Animal Source Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290015477253 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290015477253 07290015477253 7290015477253
GMDN Terms# Term, Definition table Term Definition 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 phosphate or hydroxyapatite), sometimes bioactive glasses or bioabsorbable polymers, and used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 0 Device Size Text, specify 0 Height 0 Length 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 0 0
Regulatory Flags# DUNS number 600170232 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00813954026787 SynOss Plug COLLAGEN MATRIX, INC. NPM 2025-09-05 00813954026794 SynOss Plug COLLAGEN MATRIX, INC. NPM 2025-09-05 00813954027005 PLENA Graft 0.5cc Syringe COLLAGEN MATRIX, INC. NPM 2025-08-01 00813954027012 PLENA Graft 0.5 COLLAGEN MATRIX, INC. NPM 2025-07-15 00813954026732 PuraFILL COLLAGEN MATRIX, INC. NPM 2025-03-26 00813954026749 PuraFILL COLLAGEN MATRIX, INC. NPM 2025-03-26 00813954026183 REGENAFILL COLLAGEN MATRIX, INC. NPM 2024-06-21 00813954026190 REGENAFILL COLLAGEN MATRIX, INC. NPM 2024-06-21 00813954026138 EvoBone Plug COLLAGEN MATRIX, INC. NPM 2024-03-28 00813954026145 EvoBone Plug COLLAGEN MATRIX, INC. NPM 2024-03-28 00614950028443 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028450 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028467 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028474 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028481 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028498 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028504 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00614950028511 OUSIA bioXEN ACE SURGICAL SUPPLY CO., INC. NPM 2023-06-15 00813954025315 RegenerOss COLLAGEN MATRIX, INC. NPM 2023-01-06 00813954025322 RegenerOss COLLAGEN MATRIX, INC. NPM 2023-01-06 00614950027934 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950027941 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950027958 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950027965 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950027972 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950027989 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950027996 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950028009 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950028016 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27 00614950028023 MinerOss® X ACE SURGICAL SUPPLY CO., INC. NPM 2022-10-27