Registered with FDA
Summit Packaging Solutions LLC
Hebron, KY, United States. Lists 10 dental device types with FDA across 2 registered establishments.
- Device types listed
- 10
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 2United States
Devices listed with FDA
What Summit Packaging Solutions LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Powered Toothbrush | 2016 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | Over The Counter Denture Cleanser | 2016 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Toothbrush | 2016 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Dental Floss | 2016 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Lister | Massaging Pick | 2016 |
| Oral Hygiene Rubber TipJEW · Class 1 | Floss & interdental cleaners | Lister | Oral Hygiene Rubber Tip | 2016 |
| Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt Denture AdhesiveKOO · Class 1 | Denture cleansers & adhesives | Lister | Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture | 2016 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | cavity Varnish | 2016 |
| Tongue ScraperLCN · Class 1 | — | Lister | Tongue Scraper | 2016 |
| Dental Hygiene KitNXZ · Class 1 | — | Lister | Dental Hygiene Kit | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Summit Packaging Solutions LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Procter & Gamble (3), Sylphar N.V. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Sep 2014 | K141018 | ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT | Procter & Gamble | JEQ Powered Toothbrush |
| 14 Feb 2014 | K132426 | SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS | Sylphar N.V. | LBH Cavity Varnish |
| 5 Jun 2006 | K061351 | ORAL-B SONIC COMPLETE | Procter & Gamble | JEQ Powered Toothbrush |
| 31 May 2006 | K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | Procter & Gamble | JEQ Powered Toothbrush |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Summit Packaging Solutions LLCFDA reg. 3012117640 | Jackson, GA, United States | Repacker / relabeler |
| Summit Packaging Solutions LLCFDA reg. 3012118920 | Shippensburg, PA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051178). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.