Data / Medical devices / United States / Westrock Converting, LLC
Westrock Converting, LLC: FDA-registered device maker in York, PA, United States, 3 510(k) clearances
Westrock Converting, LLC is registered with the FDA (registration 3027909953) in York, PA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 4, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027909953
- Address
- 115 Willow Springs LN, York, PA, United States, 17406
- Owner or operator
- WestRock Converting, LLC (9056422)
- Roles
- Repackager or relabeler
- First device listed
- October 13, 2023
- Registered through
- 2026
- Brand names listed
- Artificial Saliva, Biotene Dry Mouth Gentle Oral Rinse Gentle Mint; Biotene Moisturizing Spray; Biotene Oral Balance Gel, Biotene mouth spray, Poligrip Cushion Comfort; Poligrip Max Seal Denture Adhesive; Poligrip Super Denture Adhesive, Poligrip Partials; Super Polygrip Cream; Super Poligrip Cushion & Comfort; Super Poligrip Powder
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer | KOL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | KOT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Saliva, Artificial | LFD | U | Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2013 | K123731 | BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY | LFD | Substantially Equivalent | Glaxosmithkline Consumer Healthcare (Gskch) | accessdata.fda.gov |
| July 20, 2011 | K103745 | BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF | LFD | Substantially Equivalent | Glaxosmithkline Consumer Healthcare (Gskch) | accessdata.fda.gov |
| July 25, 2006 | K061331 | ORAL BALANCE LIQUID/ GEL | LFD | Substantially Equivalent | Laclede, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- All makers of Saliva, Artificial
- All makers of Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
Updated January 4, 2013. 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.