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Data / Medical devices / United States / Summit Packaging Solutions LLC

Summit Packaging Solutions LLC: FDA-registered device maker in Jackson, GA, United States, 10 510(k) clearances

Summit Packaging Solutions LLC is registered with the FDA (registration 3012117640) in Jackson, GA, United States. It lists 15 device types. The FDA files 10 510(k) clearances under its listings, the newest dated September 15, 2014. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Summit Packaging Solutions LLC
FDA registration number
3012117640
Address
950 Logistics Parkway, Jackson, GA, United States, 30233
Owner or operator
Summit Packaging Solutions LLC (10051178)
Roles
Repackager or relabeler
First device listed
February 12, 2016
Registered through
2026
Brand names listed
Dental Floss, Dental Hygiene Kit, Deodorized Scented Menstrual Pad, Deodorized Scented Menstrual Tampon, Incontience Protective Garment, Massaging Pick, Oral Hygiene Rubber Tip, Over The Counter Denture Cleanser and more

Devices it lists

DeviceProduct codeClassRoleSource
Tampon, Menstrual, Scented, Scented-DeodorizedHIL2Repackager or relabeleraccessdata.fda.gov
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double SaltKOO1Repackager or relabeleraccessdata.fda.gov
Cleanser, Denture, Over The CounterEFT1Repackager or relabeleraccessdata.fda.gov
Dental Hygiene KitNXZ1Repackager or relabeleraccessdata.fda.gov
Floss, DentalJES1Repackager or relabeleraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Repackager or relabeleraccessdata.fda.gov
Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety ProfileNRC1Repackager or relabeleraccessdata.fda.gov
Pad, Menstrual, UnscentedHHD1Repackager or relabeleraccessdata.fda.gov
Pick, MassagingJET1Repackager or relabeleraccessdata.fda.gov
Scraper, TongueLCN1Repackager or relabeleraccessdata.fda.gov
Tampon, Menstrual, UnscentedHEB2Repackager or relabeleraccessdata.fda.gov
Tip, Rubber, Oral HygieneJEW1Repackager or relabeleraccessdata.fda.gov
Toothbrush, ManualEFW1Repackager or relabeleraccessdata.fda.gov
Toothbrush, PoweredJEQ1Repackager or relabeleraccessdata.fda.gov
Varnish, CavityLBH2Repackager 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
September 15, 2014K141018ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KITJEQSubstantially EquivalentProcter & Gamble Co.accessdata.fda.gov
February 14, 2014K132426SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPSLBHSubstantially EquivalentSylphar N.V.accessdata.fda.gov
January 9, 2014K133244TAMPAX M PLASTIC TAMPONS, UNSCENTEDHEBSubstantially EquivalentThe Procter & Gamble Companyaccessdata.fda.gov
June 20, 2013K131543TAMPAX(R) L PLASTIC TAMPONS, UNSCENTEDHEBSubstantially EquivalentProcter & Gamble Co.accessdata.fda.gov
June 2, 2011K110669TAMPAX C PLASTIC TAMPONS, UNSCENTEDHEBSubstantially EquivalentThe Procter & Gamble Co.accessdata.fda.gov
June 27, 2008K081555TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTEDHILSubstantially EquivalentProcter & Gamble Co.accessdata.fda.gov
November 22, 2006K062638TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONSHEBSubstantially EquivalentProcter & Gamble Co.accessdata.fda.gov
August 1, 2006K061486TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)HEBSubstantially EquivalentProcter & Gamble Co.accessdata.fda.gov
June 5, 2006K061351ORAL-B SONIC COMPLETEJEQSubstantially EquivalentBraun GmbHaccessdata.fda.gov
May 31, 2006K061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESJEQSubstantially EquivalentBraun GmbHaccessdata.fda.gov

Compare with other makers

Updated September 15, 2014. 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.