FDA.reportPublic FDA data

Bioviva-3D Dental

Primary DI
00817169021131
Brand
Bioviva-3D Dental
Company
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Model
BPGC942
Device description
Basik PGC SUTURE USP 3/0..3/8 REV CUTTING NEEDLE 24MM LENGTH One Device
Published
2016-12-15
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
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130737000SYNTHETIC ABSORBABLE SUTUREFoosin Medical Supplies Inc., Ltd.2014-01-14GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817169021001PackageGS112In Commercial Distribution
10817169021138PackageGS112In Commercial Distribution
00817169021131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817169021001008171690210018171690210010817169021001
1081716902113810817169021138
00817169021131008171690211318171690211310817169021131

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilamentA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable needle. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080194935
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
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
08904255257412PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257443PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257450PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257467PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257474PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255257481PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-05
08904255234369PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234376PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234383PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234390PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255234406PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257306PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257313PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257320PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257337PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257344PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257351PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257368PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257375PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257382PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257399PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257405PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257429PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08904255257436PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDGAM2026-05-04
08903837198907MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2024-07-11
08903837198921MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2024-07-11
08903837149251MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-09-07
08903837149275MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-09-07
08903837149237MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2023-08-31
08809766324533V-Loc 90 DeltaSamyang Holdings CorporationGAM2023-05-31