Manufacturer registered with FDA
3D Dental Designs and Development LLC
Shaker Heights, OH, United States. Lists 51 dental device types with FDA across 1 registered establishment.
- Device types listed
- 51
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What 3D Dental Designs and Development LLC currently lists, by FDA device type, with the brand and model names on the listing.
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
3D Dental Designs and Development 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: Prime Dental Manufacturing, Inc. (4), Schutz Dental GmbH (1), Dharma Research, Inc. (1), Danville Materials, LLC (1), Delma Medical Instrument (Guangzhou) Co., Ltd. (1), Guilin Woodpecker Medical Instrument Co., Ltd. (1), Rolence Enteprise, Inc. (1), Medical Products Laboratories, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Aug 2016 | K152471 | CAPO BULK FILL | Schutz Dental GmbH | EBF Resin Tooth Shade Material |
| 23 Jun 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research, Inc. | KLE Resin Tooth Bonding Agent |
| 4 Feb 2011 | K102753 | TURBO TEMP 3 | Danville Materials, LLC | EBG Resin Temporary Crown and Bridge |
| 9 Sep 2010 | K101551 | PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M | Delma Medical Instrument (Guangzhou) Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 22 Apr 2004 | K040396 | ULTRASONIC SCALER ELEGANCE MS-10 (25K) | Rolence Enteprise, Inc. | ELC Ultrasonic Scaler |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
| 12 Jun 2002 | K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | Rolence Ent., Inc. | EBZ Ultraviolet Activator for Polymerization |
| 19 Feb 2002 | K013970 | PRIME-DENT HEMA DESENSITIZER | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 4 Sep 2001 | K011785 | NOVEL PRINT CYAN ALGINATES | Manufacturera Dental Continental | ELW Impression Material |
| 30 May 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 31 Jan 2000 | K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | EBF Resin Tooth Shade Material |
| 12 Feb 1999 | K982915 | SCI-PHARM DFV VARNISH | Scientific Pharmaceuticals | LBH Cavity Varnish |
| 1 Nov 1993 | K933543 | ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT) | Jedental Co., Inc. | EMA Dental Cement |
| 30 Dec 1980 | K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. | EJL Dental Bur |
| 8 Jul 1980 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | Crown Delta Corp. | ELW Impression Material |
| 15 Nov 1976 | K760980 | DENTAL ALLOY | Adp Intl., Inc. | EJJ Amalgam Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 3D DENTAL DESINGS AND DEVELOPMENTFDA reg. 3010864832 | Shaker Heights, OH, United States | Contract manufacturer, Repacker / relabeler |
Other names on FDA records
3D Dental Desings and Development
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10046685). 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.