FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
10841336118727
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
LV-497B
Catalog number
LV-497B
Device description
Individual Salvin 3-0 PGA PC31(PS-2) Needle Synthe
Published
2025-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K072229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072229000MONOSWIFTCp Medical2007-10-05GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841336118727PackageGS112In Commercial Distribution
00841336118720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084133611872710841336118727
00841336118720008413361187208413361187200841336118720

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester 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 device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113344790
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841336100886Salvin Dental SpecialtiesORAPLUG-PKG-10ORAPLUG-PKG-102020-02-28
00841336106413Salvin Dental SpecialtiesORBAN-1/2-SHORTORBAN-1/2-SHORT2026-06-08
00841336100480L-797BL-797B2015-10-30
00841336100381LV-493BLV-493B2018-02-22
00841336100473L-1180BL-1180B2015-10-30
00841013124457American Eagle InstrumentsAESSIRC2026-01-02
00841336104877Salvin Dental SpecialtiesGRAFT-SYR-2.8-CUGRAFT-SYR-2.8-CU2025-12-22
00841336104891Salvin Dental SpecialtiesGRAFTSYRINGE-STRGRAFTSYRINGE-STR2025-12-22
00841336104907Salvin Dental SpecialtiesGRAFT-SYR-S-CURVGRAFT-SYR-S-CURV2025-12-22
00841336104914Salvin Dental SpecialtiesGRAFT-SYR-S-STRGRAFT-SYR-S-STR2025-12-22
00841336106000Salvin Dental SpecialtiesGR11/12GR11/122025-12-22
00841336106062Salvin Dental SpecialtiesGRAFT-PACK-SERR-LGRAFT-PACK-SERR-L2025-12-22
00841336106079Salvin Dental SpecialtiesGRAFT-PACK-SERR-SGRAFT-PACK-SERR-S2025-12-22
00841336106239Salvin Dental SpecialtiesMEMB-CONDENSERMEMB-CONDENSER2025-12-22
00841336106499Salvin Dental SpecialtiesPIKOS-PACKERPIKOS-PACKER2025-12-22
00841336106697Salvin Dental SpecialtiesSINUS-DETACHSINUS-DETACH2025-12-22
00841336106802Salvin Dental SpecialtiesSUGARMAN-1S/2SSUGARMAN-1S/2S2025-12-22
00841336106819Salvin Dental SpecialtiesSUGARMAN-3S/4SSUGARMAN-3S/4S2025-12-22
00841336106918Salvin Dental SpecialtiesYG7/8YG7/82025-12-22
00841336108639Salvin Dental SpecialtiesIMPLA-SAFE-EXPLORERIMPLA-SAFE-EXPLORER2025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046963535797NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535810NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535995NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536176NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536213NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535438NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535537NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535636NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535674NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534578NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534752NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534776NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963534998NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535278NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535315NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535339NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535391NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535575NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535698NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963535971NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536015NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536138NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536190NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536251NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536275NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536312NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536350NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536596NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536695NovosynB BRAUN SURGICAL SAGAM2015-08-12
04046963536770NovosynB BRAUN SURGICAL SAGAM2015-08-12