FDA.reportPublic FDA data

Bioviva by 3D Dental

Primary DI
00810126506795
Brand
Bioviva by 3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
SCG1654
Device description
"BIOVIVA SUTURE CHROMIC GUT REVERSE CUTTING 4/0 P-3 3/8 18"" 13MM "
Published
2026-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GALSuture, Absorbable, Natural

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GALSuture, Absorbable, NaturalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810126506792PackageGS112In Commercial Distribution
00810126506795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081012650679210810126506792
00810126506795008101265067958101265067950810126506795

GMDN Terms#

Term, Definition table
TermDefinition
Catgut suture, chromicA single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines), impregnated with chromium salts to increase tensile strength and retard absorption, intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080194935
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126508362Essentials By 3D DentalGN300-L2026-04-16
008101265062213D DentalRCPC2026-03-24
00810126506757Comfortox5CC30132026-03-24
00810126506764Comfortox5CC2982026-03-24
00810126508355Basik by 3D DentalBPGLA4672026-03-17
00810126508331Basik by 3D DentalBPGC9422026-03-17
00810126508348Basik by 3D DentalBPGC9432026-03-17
10817169023019Basik by 3D DentalBPGLA4672026-03-17
008171690214833D Dental - DreamDFVMLDFVML2023-01-11
00817169023005Basik by 3D DentalBPGLA4532026-03-17
00810126506054The Essentials By 3D DentalPL-HCSPL-HCS2023-02-28
00810126506061The Essentials By 3D DentalPL-HRLGPL-HRLG2023-02-28
008171690201723D Dental - DreamDFVBG2016-12-12
008171690201893D Dental - DreamDFVSM2016-12-12
008171690214763D Dental-DreamDFVCM2017-12-04
008171690219643D Dental- BiovivaBHG2018-08-30
008101265081643D DentalJSM-CN2026-03-16
008101265081713D DentalJSM-CW2026-03-16
008101265081883D DentalJSM-N2026-03-16
008101265081953D DentalJSM-W2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052417SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052424SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052431SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052448SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052462SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052486SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052684SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052691SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052707SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052714SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052721SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052738SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052745SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052752SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052776SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052783SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052790SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052806SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052813SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052820SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052837SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052844SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052851SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052875SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052882SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052899SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052905SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052912SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052929SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06
00848782052936SharpointSurgical Specialties México, S. de R.L. de C.V.GAL2026-07-06