FDA.report

REGENEROSS®

Primary DI
00844868028246
Brand
REGENEROSS®
Company
BIOMET 3I, LLC
Model
ROAPM20
Device description
DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
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
00844868028246PrimaryGS10
30844868028247Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844868028246008448680282468448680282460844868028246
3084486802824730844868028247

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
4
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

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00844868051992Single Patient ACT® Twist DrillSPACT38102025-12-18
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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