FDA.reportPublic FDA data

RegenaVate™ Formable DBM RT, 2cc

Primary DI
00191083045115
Brand
RegenaVate™ Formable DBM RT, 2cc
Company
Rti Surgical, Inc.
Model
ZR0202
Catalog number
005302Z
Published
2024-05-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NUNBONE GRAFTING MATERIAL, HUMAN SOURCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUNBone Grafting Material, Human SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080418000REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PASTRegeneration Technologies, Inc.2008-04-30NUN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854095006771PreviousGS10
00191083045115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854095006771008540950067718540950067710854095006771
00191083045115001910830451151910830451150191083045115

GMDN Terms#

Term, Definition table
TermDefinition
Human-derived demineralized bone matrix implantAn 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 fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Regulatory Flags#

DUNS number
117560455
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccZR0302001510Z2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccZR0201005301Z2024-05-27
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccZR0305001504Z2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccZR0301001505Z2024-05-27
10885862093196OPTEFORM® Allograft Full Disc, 3 x 20mm, 1cc002523600-03-202015-11-06
10885862093202OPTEFORM® Allograft Disc, 30mm x 3mm, 2cc002530600-03-302015-11-06
10885862093219OPTEFORM® Allograft Disc, 45mm x 5mm, 8cc002545600-05-452015-11-06
10885862093226OPTEFORM® Allograft Full Disc, 5 x 90mm, 32cc002529600-05-902015-11-06
10885862094094OPTEFORM® Allograft Partial Disc, 75mm x 5mm, 15cc002575602-05-752015-11-06
10885862094100OPTEFORM® Allograft Partial Disc, 90mm x 5mm, 22cc002590602-05-902015-11-06
10885862094223OPTEFORM® Allograft Paste, 2cc005102606-01-022015-11-06
10885862094230OPTEFORM® Allograft Paste, 5cc005105606-01-052015-11-06
10885862094247OPTEFORM® Allograft Paste, 10cc005110606-01-102015-11-06
10885862094254OPTEFORM® Allograft Paste, 20cc005120606-01-202015-11-06
10885862094384OPTEFIL® Allograft Paste, 1cc005001616-01-012015-11-06
10885862094391OPTEFIL® Allograft Paste, 5cc005005616-01-052015-11-06
10885862094407OPTEFIL® Allograft Paste, 10cc005010616-01-102015-11-06
10885862094599Synergent™ DBM, 1cc004901630-00-012015-11-06
10885862094605Synergent™ DBM, 5cc004905630-00-052015-11-06
10885862094612Synergent™ DBM, 10cc004910630-00-102015-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809963478848SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478855SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478862SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478879ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478886ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478893ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
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
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2024-12-05
00841336111905Allo-3D-PlusSALVIN DENTAL SPECIALTIES, LLCNUN2024-07-11
00841336111912Allo-3D-PlusSALVIN DENTAL SPECIALTIES, LLCNUN2024-07-11
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccRti Surgical, Inc.NUN2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccRti Surgical, Inc.NUN2024-05-27
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
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, LLCNUN2018-02-22
00841336100237ALLO-1.0SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22
00841336100244ALLO-2.0SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22