FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
10841336117645
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
L-1265B
Catalog number
L-1265B
Device description
Individual 5-0 Silk C3 Needle 18 inch (45cm)
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
GAPSuture, nonabsorbable, silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001184000SILK, NONABSORBABLE, SURGICAL SUTURES, USPCp Medical2000-06-23GAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841336117645PackageGS112In Commercial Distribution
00841336117648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084133611764510841336117645
00841336117648008413361176488413361176480841336117648

GMDN Terms#

Term, Definition table
TermDefinition
Silk sutureA natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. 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
00841336111905Allo-3D-PlusALLO-3D-PLUS-1.0ALLO-3D-PLUS-1.02024-07-11
00841336111912Allo-3D-PlusALLO-3D-PLUS-2.0ALLO-3D-PLUS-2.02024-07-11
00841336138766Salvin Dental SpecialtiesOFIBER-0.5CCOFIBER-0.5CC2025-09-28
00841336138773Salvin Dental SpecialtiesOFIBER-1.0CCOFIBER-1.0CC2025-09-28
00841336138797Salvin Dental SpecialtiesOFIBER-PLUS-0.5CCOFIBER-PLUS-0.5CC2025-09-28
00841336138803Salvin Dental SpecialtiesOFIBER-PLUS-1.0CCOFIBER-PLUS-1.0CC2025-09-28
00841336114395Salvin Dental SpecialtiesDEMIN-CORT-L-5.0DEMIN-CORT-L-5.02024-12-11
00841336125704Salvin Dental SpecialtiesSALVINOSS-0.5SALVINOSS-0.52024-12-11
00841336125711Salvin Dental SpecialtiesSALVINOSS-1.0SALVINOSS-1.02024-12-11
00841336125728Salvin Dental SpecialtiesSALVINOSS-2.5SALVINOSS-2.52024-12-11
00841336125735Salvin Dental SpecialtiesSALVINOSS-COLL-100MGSALVINOSS-COLL-100MG2024-12-11
00841336125759Salvin Dental SpecialtiesSALVINOSS-COLL-250MGSALVINOSS-COLL-250MG2024-12-11
00841336136229Salvin Dental SpecialtiesMIN-CAN-2.00MIN-CAN-2.002024-12-11
00841336138780Salvin Dental SpecialtiesOFIBER-2.5CCOFIBER-2.5CC2024-12-11
00841336111929SALVINOSS-BSALVINOSS-B-0.52024-05-27
00841336111936SALVINOSS-BSALVINOSS-B-1.02024-05-27
00841336111943SALVINOSS-BSALVINOSS-B-2.02024-05-27
00841336111950SALVINOSS-BSALVINOSS-B-4.02024-05-27
00841336111998SALVINOSS-BSALVINOSS-B-SYR-0.252024-05-27
00841336112001SALVINOSS-BSALVINOSS-B-SYR-0.502024-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00381780363883Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGAP2017-01-05
04038653826230SilkamB BRAUN SURGICAL SAGAP2015-11-12
04038653826469SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653826513SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653741502SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741526SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741601SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741700SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741786SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741816SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741830SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741854SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741892SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741915SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742196SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742257SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742271SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742776SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742936SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742950SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742974SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742998SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741243SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741281SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741403SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741441SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741625SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743131SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743438SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743414SilkamB BRAUN SURGICAL SAGAP2015-08-20