FDA.report

REGENEROSS®

Primary DI
00844868035510
Brand
REGENEROSS®
Company
BIOMET 3I, LLC
Model
ROAP20
Device description
DEMINERALIZED BONE MATRIX (DMB) 2.0CC
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NUNBONE GRAFTING MATERIAL, HUMAN SOURCE

Product Code Classifications

CodeDeviceSpecialtyClass
NUNBone Grafting Material, Human SourceDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844868035510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868035510008448680355108448680355100844868035510

GMDN Terms

TermDefinition
Dental bone matrix implant, human-derivedA sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to augment/reconstruct maxillofacial and/or mandibular bone by filling bone voids or gaps caused by trauma or dental surgery. It is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is typically available in the form of a sterile powder, crushed granules, putty, chips, or gel injected with syringe.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)342-54543iPBG-CS@biomet.com

Regulatory Flags

DUNS number
186127825
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
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

Primary DIBrandModelCatalogPublished
00844868051824Single Patient ACT® Twist DrillSPACT20152025-12-18
00844868051831Single Patient ACT® Twist Drill, 2mmD x 10mmLSPACT20102025-12-18
00844868051848Single Patient ACT® Twist DrillSPACT20202025-12-18
00844868051855Single Patient ACT® Twist DrillSPACT206S2025-12-18
00844868051862Single Patient ACT® Twist DrillSPACT27102025-12-18
00844868051879Single Patient ACT® Twist DrillSPACT27152025-12-18
00844868051886Single Patient ACT® Twist DrillSPACT27202025-12-18
00844868051893Single Patient ACT® Twist DrillSPACT30102025-12-18
00844868051909Single Patient ACT® Twist DrillSPACT30152025-12-18
00844868051916Single Patient ACT® Twist DrillSPACT30202025-12-18
00844868051923Single Patient ACT® Twist DrillSPACT31102025-12-18
00844868051930Single Patient ACT® Twist DrillSPACT31152025-12-18
00844868051947Single Patient ACT® Twist DrillSPACT31202025-12-18
00844868051954Single Patient ACT® Twist DrillSPACT32102025-12-18
00844868051961Single Patient ACT® Twist DrillSPACT32152025-12-18
00844868051978Single Patient ACT® Twist DrillSPACT32202025-12-18
00844868051985Single Patient ACT® Twist DrillSPACT326S2025-12-18
00844868051992Single Patient ACT® Twist DrillSPACT38102025-12-18
00844868052005Single Patient ACT® Twist DrillSPACT38152025-12-18
00844868052012Single Patient ACT® Twist DrillSPACT38202025-12-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841336138766Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138773Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138797Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138803Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336114395Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00841336136229Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00841336138780Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccRti Surgical, Inc.NUN2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccRti Surgical, Inc.NUN2024-05-27
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00643169965003GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-08-17
00643169964952GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-07-12
00643169964990GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-06-11
00841336100220ALLO-0.5Salvin Dental Specialties, Inc.NUN2018-02-22
00841336100237ALLO-1.0Salvin Dental Specialties, Inc.NUN2018-02-22
00841336100244ALLO-2.0Salvin Dental Specialties, Inc.NUN2018-02-22
00841336100251ALLO-3D-.5Salvin Dental Specialties, Inc.NUN2018-02-22
00841336100268ALLO-3D-1.0Salvin Dental Specialties, Inc.NUN2018-02-22
00841336100275ALLO-3D-2.0Salvin Dental Specialties, Inc.NUN2018-02-22
00643169964983GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-01-26
00643169964969GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-01-21
00643169964976GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2017-12-15
00643169965010GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2017-12-15
00643169134287GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2016-04-03
00643169134294GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2016-04-03
00643169134300GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2016-04-03