FDA.reportPublic FDA data

Salvin Dental Specialties

Primary DI
00841336103627
Brand
Salvin Dental Specialties
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
MEMB-PUNCH
Device description
Salvin Membrane Punch
Published
2023-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMEPunch, Biopsy, Surgical
EMMChisel, Osteotome, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMEPunch, Biopsy, SurgicalDental1
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841336103627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336103627008413361036278413361036270841336103627

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. 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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00841336108653Salvin Dental SpecialtiesIMPLA-SAFE-SOFT-TI-CURETTEIMPLA-SAFE-SOFT-TI-CURETTE2025-12-22
00841336109421Salvin Dental SpecialtiesH6/H7H6/H72025-12-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10080196025749MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
10080196028993MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
10080196029099MedlineMEDLINE INDUSTRIES, INC.EME2024-09-30
10080196024858MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
10080196024940MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
10080196028917MedlineMEDLINE INDUSTRIES, INC.EME2024-09-27
GYNX13101GynexGYNEX CORPORATIONEME2023-06-29
GYNX13221GynexGYNEX CORPORATIONEME2023-06-29
GYNX13231GynexGYNEX CORPORATIONEME2023-06-29
GYNX13241GynexGYNEX CORPORATIONEME2023-06-29
GYNX1325GynexGYNEX CORPORATIONEME2023-06-29
GYNX13261GynexGYNEX CORPORATIONEME2023-06-29
GYNX13281GynexGYNEX CORPORATIONEME2023-06-29
08056646504770Punches, NOBELOMNIA SRLEME2021-08-09
08056646504794Punches, NOBELOMNIA SRLEME2021-08-09
08056646504817Punches, NOBELOMNIA SRLEME2021-08-09
08056646504831Punches, NOBELOMNIA SRLEME2021-08-09
08056646504855Punches, NOBELOMNIA SRLEME2021-08-09
08056646504879Punches, NOBELOMNIA SRLEME2021-08-09
ESAM13290011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291021STOMA®Storz am Mark GmbHEMM2020-08-27