Data / Medical devices / United States / Dentonics, Inc.
Dentonics, Inc.: FDA-registered device maker in Monroe, NC, United States, 23 510(k) clearances
Dentonics, Inc. is registered with the FDA (registration 1721647) in Monroe, NC, United States. It lists 12 device types. The FDA files 23 510(k) clearances under its listings, the newest dated May 23, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1721647
- Address
- 2833 Tophill RD., Monroe, NC, United States, 28110
- Owner or operator
- DENTONICS, INC. (1721647)
- Roles
- Repackager or relabeler
- First device listed
- November 16, 2001
- Registered through
- 2026
- Brand names listed
- Master-Dent, Master-Dent Anterior/Posterior Composite Restorative, Master-Dent Core Build-Up Material, Material, Tooth Shade, Resin, Root Canal Sealer
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Repackager or relabeler | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | 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 |
|---|---|---|---|---|---|---|
| May 23, 2022 | K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | KIF | Substantially Equivalent | Prevest Denpro Limited | accessdata.fda.gov |
| September 28, 2012 | K121915 | BRIGHT RESTORATIVE MATERIALS | EBF | Substantially Equivalent | Dmp, Ltd. | accessdata.fda.gov |
| August 4, 2004 | K041886 | PROVISO | EBG | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| May 14, 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| July 21, 2000 | K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | DYH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| January 7, 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| December 13, 1993 | K934184 | FASTFIL | EMA | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| October 5, 1990 | K903551 | TEMPOREX | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| April 16, 1990 | K895386 | GLASION | EMA | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| December 2, 1988 | K884081 | INTERIM, TEMPORARY CEMENT | EMA | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| November 12, 1987 | K873686 | DIAMOND-LUSTER DENTAL POLISHING PASTE | EJR | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| April 11, 1986 | K860633 | FLUOROSEAL, DENTIN SEALER AND CAVITY LINER | LBH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| September 7, 1984 | K843098 | APCO FISSURE SEALER & BONDING AGENT | EBC | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| August 17, 1984 | K842403 | LUSTER, DENTAL POLISHING PASTE | EJR | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| February 21, 1984 | K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| October 19, 1983 | K832781 | CURAY-SUPPORT, CORE BUILD-UP MATERIAL | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 18, 1983 | K831495 | CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO | DYH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| December 28, 1982 | K823510 | CURAY ANTERIOR/POSTERIOR RESTORATIVE | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 8, 1980 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| November 30, 1979 | K792140 | COMPOSITE RESTORATIVE, PASTE/TYPE | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| August 10, 1979 | K791132 | SCI-PHARM ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| August 10, 1979 | K791078 | ANTERIOR/POSTERIOR RESTORATIVE, BOND | EBD | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 6, 1979 | K790788 | FISSURE SEALER AND BONDING AGENT | EBC | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Material, Tooth Shade, Resin
- All makers of Resin, Root Canal Filling
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
Updated May 23, 2022. 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.