FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336108318
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
ZAGA-5
Catalog number
ZAGA-5
Device description
Salvin ZAGA 5 - Nasal Protector Double Ended Hexagonal Handle
Published
2025-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336108318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336108318008413361083188413361083180841336108318

GMDN Terms#

Term, Definition table
TermDefinition
Dental drill bit extensionA device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
113344790
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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

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Primary DI, Brand, Company table
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00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17