FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336122147
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
MEIS-HM141F-014-RAXL
Catalog number
MEIS-HM141F-014-RAXL
Device description
#4 Round Sharp Bone Cutting Bur
Published
2024-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336122147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336122147008413361221478413361221470841336122147

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
113344790
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841336108653Salvin Dental SpecialtiesIMPLA-SAFE-SOFT-TI-CURETTEIMPLA-SAFE-SOFT-TI-CURETTE2025-12-22
00841336109421Salvin Dental SpecialtiesH6/H7H6/H72025-12-22
00841336111158Salvin Dental SpecialtiesPIKOS-PACKER-ANGLEDPIKOS-PACKER-ANGLED2025-12-22
00841336112063Salvin Dental Specialties204S204S2025-12-22
00841336128811Salvin Dental SpecialtiesIMPLA-SAFE-BRUSH2025-11-20

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Primary DI, Brand, Company table
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D7717270061Dental CityICP, INC.EJL2026-05-26
D7717270081Dental CityICP, INC.EJL2026-05-26
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D7717271041Dental CityICP, INC.EJL2026-05-26
D7717271061Dental CityICP, INC.EJL2026-05-26
D7717271081Dental CityICP, INC.EJL2026-05-26
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D7717275721Dental CityICP, INC.EJL2026-05-26
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D7717276131Dental CityICP, INC.EJL2026-05-26
D7717276421Dental CityICP, INC.EJL2026-05-26
D7717276641Dental CityICP, INC.EJL2026-05-26
D7717276761Dental CityICP, INC.EJL2026-05-26