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Data / Medical devices / United States / Salvin Dental Specialties, LLC

Salvin Dental Specialties, LLC: FDA-registered device maker in Charlotte, NC, United States, 27 510(k) clearances

Salvin Dental Specialties, LLC is registered with the FDA (registration 1066741) in Charlotte, NC, United States. It lists 75 device types. The FDA files 27 510(k) clearances under its listings, the newest dated May 1, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Salvin Dental Specialties, LLC
FDA registration number
1066741
FEI number
3003005156
Address
3450 Latrobe Dr, Charlotte, NC, United States, 28211
Owner or operator
Young Innovations Inc (9046427)
Roles
Manufacturer for export, Repackager or relabeler, Specification developer
First device listed
June 6, 2001
Registered through
2026
Brand names listed
AMPLIFI Long Term Membrane, AlloSculpt 3D Plus, Allosculpt, AmpliDerm, BIO-PRF, BONE FILE, BONE-SCRAPER, Bone Block Holder and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Repackager or relabeleraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Repackager or relabeleraccessdata.fda.gov
Applicator, Absorbent Tipped, Non-SterileKXF1Repackager or relabeleraccessdata.fda.gov
Barrier, Animal Source, IntraoralNPL2Repackager or relabeleraccessdata.fda.gov
Barrier, Synthetic, IntraoralNPK2Specification developeraccessdata.fda.gov
Blade, ScalpelGES1Repackager or relabeleraccessdata.fda.gov
Bone Grafting Material, Animal SourceNPM2Repackager or relabeleraccessdata.fda.gov
Bone Grafting Material, Human SourceNUN2Repackager or relabeler, Specification developeraccessdata.fda.gov
Bone Grafting Material, SyntheticLYC2Repackager or relabeleraccessdata.fda.gov
Bone MillLYS1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
CaliperKTZ1Repackager or relabeleraccessdata.fda.gov
Chair, Dental, Without Operative UnitNRU1Repackager or relabeleraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Repackager or relabeleraccessdata.fda.gov
Curette, OperativeEKE1Repackager or relabeleraccessdata.fda.gov
Curette, PeriodonticEMS1Repackager or relabeleraccessdata.fda.gov
Curette, Surgical, DentalEMK1Repackager or relabeleraccessdata.fda.gov
Depressor, Metal Tongue, SurgicalKBL1Repackager or relabeleraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeleraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeleraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Repackager or relabeleraccessdata.fda.gov
File, Bone, SurgicalEMI1Repackager or relabeleraccessdata.fda.gov
File, PeriodonticEMR1Repackager or relabeleraccessdata.fda.gov
ForcepsHTD1Repackager or relabeleraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Gag, MouthKBN1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Repackager or relabeleraccessdata.fda.gov
General Surgery TrayLRO2Manufacturer for exportaccessdata.fda.gov
Gown, SurgicalFYA2Repackager or relabeleraccessdata.fda.gov
Handle, Instrument, DentalEJB1Repackager or relabeleraccessdata.fda.gov
Handle, ScalpelGDZ1Repackager or relabeleraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeleraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Repackager or relabeleraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeleraccessdata.fda.gov
Light, Fiber Optic, DentalEAY1Repackager or relabeleraccessdata.fda.gov
MalletHXL1Repackager or relabeleraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Repackager or relabeleraccessdata.fda.gov
Marker, PeriodonticEMP1Repackager or relabeleraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Needle, DentalDZM1Repackager or relabeleraccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Specification developeraccessdata.fda.gov
Plate, BoneJEY2Repackager or relabeleraccessdata.fda.gov
Pliers, OperativeEJY1Repackager or relabeleraccessdata.fda.gov
Pliers, SurgicalHTC1Repackager or relabeleraccessdata.fda.gov
Probe, PeriodonticEIX1Repackager or relabeleraccessdata.fda.gov
Punch, Biopsy, SurgicalEME1Repackager or relabeleraccessdata.fda.gov
Punch, SurgicalLRY1Repackager or relabeleraccessdata.fda.gov
Remover, CrownEIS1Repackager or relabeleraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scissors, Collar And CrownEIR1Repackager or relabeleraccessdata.fda.gov
Scissors, General, SurgicalLRW1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Screw, Fixation, IntraosseousDZL2Repackager or relabeler, Specification developeraccessdata.fda.gov
ScrewdriverHXX1Repackager or relabeleraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, NaturalGAL2Repackager or relabeleraccessdata.fda.gov
Suture, Absorbable, Synthetic, Polyglycolic AcidGAM2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, SilkGAP2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyamideGAR2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Repackager or relabeleraccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolypropyleneGAW2Repackager or relabeleraccessdata.fda.gov
Suture, Surgical, Nonabsorbable, Expanded, PolytetraflouroethyleneNBY2Repackager or relabeleraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Repackager or relabeleraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Tape, Measuring, Rulers And CalipersFTY1Repackager or relabeleraccessdata.fda.gov
Tray, SurgicalLRP1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Repackager or relabeleraccessdata.fda.gov
TrephineHWK1Repackager or relabeleraccessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)KGNURepackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 1, 2024K233203Soft Tissue Augmentation Resorbable MatrixNPLSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
September 10, 2020K193212DSM Biomedical Dental Bone Graft PlusNPMSubstantially EquivalentDsm Biomedicalaccessdata.fda.gov
March 26, 2018K173922C-PTFETM Surgical SutureNBYSubstantially EquivalentCp Medical, Inc.accessdata.fda.gov
May 16, 2017K170245DSM Biomedical Dental Bone GraftNPMSubstantially EquivalentKensey Nash Corporation Dba Dsm Biomedicalaccessdata.fda.gov
April 28, 2017K161857Salvin Tenting Screw SystemDZLSubstantially EquivalentSalvin Dental Specialtiesaccessdata.fda.gov
September 8, 2016K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmNPKSubstantially EquivalentSalvin Dental Specialtiesaccessdata.fda.gov
June 23, 2016K152600Collagen Dental Wound DressingsKGNSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
June 7, 2016K160474DSM Biomedical Porcine Pericardium Dental MembraneNPLSubstantially EquivalentKensey Nash Corporation Dba Dsm Biomedicalaccessdata.fda.gov
July 11, 2013K121310MESOTHELIUM DENTAL MEMBRANENPLSubstantially EquivalentKensey Nash Corporationaccessdata.fda.gov
August 12, 2011K103699EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCCNUNSubstantially EquivalentExactech, Inc.accessdata.fda.gov
July 29, 2011K110600COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGENNPLSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
August 11, 2010K100156COLLAGEN DENTAL MEMBRANE VNPLSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
May 10, 2010K100182SALVIN DENTAL SPECIALTIES FIXATION SCREWDZLSubstantially EquivalentSalvin Dental Specialties, Inc.accessdata.fda.gov
March 15, 2010K093122MBCP+LYCSubstantially EquivalentBiomatlanteaccessdata.fda.gov
February 12, 2009K083742SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIXLYCSubstantially EquivalentCollagen Matrix, Inc.accessdata.fda.gov
April 30, 2008K080418REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PASTNUNSubstantially EquivalentRegeneration Technologies, Inc.accessdata.fda.gov
March 26, 2008K073342SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREWDZLSubstantially EquivalentSalvin Dental Specialties, Inc.accessdata.fda.gov
October 5, 2007K072229MONOSWIFTGAMSubstantially EquivalentCp Medicalaccessdata.fda.gov
May 26, 2005K050669JEIL BONE FIXATION SYSTEMJEYSubstantially EquivalentJeil Medical Corporationaccessdata.fda.gov
July 12, 2001K011786VACUETTE SAFETY BLOOD COLLECTION SETFMISubstantially EquivalentGreiner Vacuette North America, Inc.accessdata.fda.gov
June 23, 2000K001299PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USPGALSubstantially Equivalent for Some IndicationsCp Medicalaccessdata.fda.gov
June 23, 2000K001185POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USPGAWSubstantially Equivalent for Some IndicationsCp Medicalaccessdata.fda.gov
June 23, 2000K001184SILK, NONABSORBABLE, SURGICAL SUTURES, USPGAPSubstantially Equivalent for Some IndicationsCp Medicalaccessdata.fda.gov
June 23, 2000K001173NYLON, NONABSORBABLE SURGICAL SUTURES USPGARSubstantially Equivalent for Some IndicationsCp Medicalaccessdata.fda.gov
February 25, 1997K964142MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNSKKXSubstantially EquivalentMedline Industries, Inc.accessdata.fda.gov
November 10, 1994K943949POLYVIOLENE SURGICL SUTUREGATSubstantially Equivalent for Some IndicationsLook, Inc.accessdata.fda.gov
May 31, 1990K896554GUT SUTURESGALSubstantially Equivalent for Some IndicationsLook, Inc.accessdata.fda.gov

Compare with other makers

Updated May 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.