Registered with FDA
Signa Medical, Inc.
Groveport, OH, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Signa Medical, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | DenMat Bulk Fill; Evanesce Bulk FillDenMat Tenure; Tenure MPBMATERIAL, TOOTH SHADE, RESIN | 2025 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Chocolate Bite; Clear Bite; Mega Bite; Vanilla BiteMATERIAL, IMPRESSIONSplash Max; Splash! | 2025 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Bio-Cap; Block-Out Try-In; Duo PCH; Duo:PCH Cement; Geristore; GoldLink 2; Holistore; Infinity; Infinity SE; LumineersCEMENT, DENTAL | 2025 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Dental FlossFLOSS, DENTAL | 2024 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | BondLink; Gloss 'N' Seal; LumiBrite Desensitizing Enhancer; Tenure Quik with Fluoride; Tenure S; Tenure Uni-BondTOOTH BONDING AGENT | 2025 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | Denmat Ceri-Sander | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | TOOTHBRUSH, POWERED | 2025 |
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
Signa Medical, Inc. 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: Den-Mat Corp. (3), Procter & Gamble (2), Philips Medical Systems International BV (2), 3M Company (2), Den-Mat Holdings, LLC (1), 3M Espe Dental Products (1), 3M Espe AG Dental Products (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Oct 2024 | K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | EBF Resin Tooth Shade Material |
| 5 May 2011 | K111185 | RELYX LUTING PLUS AUTOMIX | 3M Espe Dental Products | EMA Dental Cement |
| 31 May 2006 | K061199 | ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES | Procter & Gamble | JEQ Powered Toothbrush |
| 24 Apr 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products | KLE Resin Tooth Bonding Agent |
| 5 Aug 2005 | K052090 | SPLASH! IMPRESSION MATERIAL DEVICE | Philips Medical Systems International BV | ELW Impression Material |
| 9 May 2003 | K030776 | MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL | Philips Medical Systems International BV | ELW Impression Material |
| 9 Aug 1999 | K991961 | 3M LVR SYSTEM | 3M Company | EBF Resin Tooth Shade Material |
| 28 Jan 1993 | K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | Procter & Gamble | JES Dental Floss |
| 15 Jul 1988 | K881918 | LIGHT-CURED ZIONOMER CEMENT | Den-Mat Corp. | EMA Dental Cement |
| 24 Aug 1987 | K872510 | DEN-MAT TENURE | Den-Mat Corp. | EBF Resin Tooth Shade Material |
| 28 May 1980 | K801216 | DEN-MAT DENTIN BONDING AGENT | Den-Mat Corp. | KLE Resin Tooth Bonding Agent |
| 18 Mar 1980 | K800485 | VINYL POLYSILOXANE IMPRESSION MATERIAL | 3M Company | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SIGNA MEDICAL, INC.FDA reg. 3010419931 | Long Beach, NY, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045410). 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.