Data / Medical devices / United States / Pulpdent Corporation
Pulpdent Corporation: FDA-registered device maker in Watertown, MA, United States, 56 510(k) clearances
Pulpdent Corporation is registered with the FDA (registration 1215305) in Watertown, MA, United States. It lists 37 device types. The FDA files 56 510(k) clearances under its listings, the newest dated April 1, 2016. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1215305
- Address
- 80 Oakland St, Watertown, MA, United States, 02472
- Owner or operator
- PULPDENT CORPORATION (1215305)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 19, 1977
- Registered through
- 2026
- Brand names listed
- 'T'-Bands, 17% SOLUTION, 2.5% Nitric Acid Etchant, ACTIVA BioACTIVE BASE / LINER, ACTIVA BioACTIVE BULK FLOW, ACTIVA BioACTIVE CEMENT, ACTIVA BioACTIVE RESTORATIVE, ACTIVA KIDS BioACTIVE BULK FLOW and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 1, 2016 | K153249 | Pulpdent Solo Flowable Composite with MCP | EBF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| March 29, 2013 | K130223 | RMGI FILL | EMA | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| December 7, 2012 | K123265 | RMGI LOW VISCOSITY | EMA | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| June 8, 2012 | K120784 | TUFF-TEMP 2.0 | EBG | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| April 5, 2012 | K120003 | NUCAL | EJK | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| December 9, 2011 | K112946 | ACTIV VARNISH | LBH | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| March 10, 2010 | K093620 | PULPDENT FLUORIDE VARNISH | LBH | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| May 11, 2009 | K090391 | PULPDENT MICRO-HYBRID COMPOSITE | EBF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| September 17, 2008 | K081810 | PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| June 29, 2007 | K071278 | EMBRACE DUAL CURE COMPOSITE MATERIALS | EBF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| February 8, 2006 | K052281 | EMBRACE WETBOND CLEAR SEALANT | EBC | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| April 20, 2004 | K040236 | PULPDENT VLC RESIN CEMENT | EMA | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| December 10, 2003 | K032953 | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT | KLE | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| August 5, 2003 | K031915 | PULPDENT ETCH-RITE ROYALE | KLE | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| August 1, 2003 | K031877 | EMBRACE WET-BOND RESTORATIVE MATERIAL | EBF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| October 11, 2002 | K022492 | PULPDENT SEMI-GEL ETCH | EBF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| October 7, 2002 | K022734 | PULPDENT CALCIUM HYDROXIDE PREPARATION | KIF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| September 26, 2002 | K022522 | PULPDENT PUTTY DAM | EIE | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| April 17, 2002 | K020481 | PULPDENT POST CEMENT | EMA | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| April 17, 2002 | K020432 | PULPDENT GLAZE | EBF | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| April 12, 2002 | K020287 | DENTITION INTEGRATING MATERIAL | EBC | Substantially Equivalent | Pulpdent Corporation | accessdata.fda.gov |
| December 13, 1999 | K993683 | PULPDENT UNO-DUO | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| December 17, 1997 | K974014 | PULPDENT DENTASTIC UNO | EMA | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| October 2, 1997 | K972445 | PULPDENT OX-OUT | EMA | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 12, 1997 | K971594 | FLOW-RITE | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| January 17, 1997 | K964430 | PULPDENT SNOOP | LFC | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| October 11, 1996 | K963652 | PULPDENT DESENSITIZER | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 30, 1996 | K962747 | PULPDENT ENDODONTIC POST CEMENT KIT | EMA | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 3, 1996 | K962383 | PULPDENT RESILUTE II | EMA | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| April 23, 1996 | K961089 | PULPDENT ENDOPREP II | EKL | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| August 7, 1995 | K953079 | LIMELIGHT | EJK | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| July 14, 1995 | K952854 | PULPDENT GLASS IONOMER CEMENTS | DYH | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| May 31, 1995 | K951270 | PULPDENT GLASS IONOMER CEMENTS | EMA | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| January 20, 1995 | K946138 | PULPDENT ROOT CANAL SEALER | KIF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| December 14, 1994 | K945056 | PULPDENT RESIN CEMENT | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| November 30, 1994 | K944945 | PULPDENT CALCIUM HYDROXIDE PREPARATIONS | EJK | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 20, 1993 | K932794 | PULPDENT SEAL-RITE LOW VISCOSITY | EBC | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 13, 1993 | K932793 | PULPDENT 2.5% NITRIC ACID ETCHANT | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| August 24, 1993 | K931710 | PULPDENT DENTAL BOND ENHANCER 2-B | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| April 20, 1993 | K930989 | PULPDENT UNFILLED DUAL CURE BONDING RESIN | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| March 16, 1993 | K926074 | PULPDENT DENTAL BOND ENCHANCER | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| August 20, 1992 | K922755 | PULPDENT HARD CORE | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| April 29, 1992 | K920483 | 10% PHOSPHORIC ACID ETCHING GEL | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| September 6, 1991 | K911282 | PULPDENT ENAMEL BONDING AGENT | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| July 5, 1991 | K911286 | PULPDENT ORTHODONTIC BRACKET ADHESIVE | DYH | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| June 10, 1991 | K911287 | PULPDENT SEAL RITE | EBC | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| May 15, 1991 | K911281 | PULPDENT PIC N STIC | EKJ | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| July 13, 1990 | K902023 | SEAL RITE PROCEDURE KIT(TM) | EBC | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| May 29, 1990 | K901049 | COPAL VARNISH | LBH | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| April 30, 1990 | K901051 | 22% POLYACRYLIC ACID GEL | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| February 14, 1990 | K896659 | SILANE | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| February 14, 1990 | K896655 | 9.6% HYDROFLUORIC ACID GEL | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| February 14, 1990 | K896654 | DRYING AGENT | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
| July 15, 1988 | K882576 | ACID ETCH GEL | EBF | Substantially Equivalent | Pulpdent Corp. of America | accessdata.fda.gov |
| October 16, 1985 | K853447 | POLYCARB WATER SET | EMA | Substantially Equivalent | Pulpdent Corp. of America | accessdata.fda.gov |
| March 24, 1981 | K810545 | PCA PERIOCARE PERIODONTAL DRESSING | EMA | Substantially Equivalent | Pulpdent Corp. of America | accessdata.fda.gov |
Compare with other makers
- All makers of Zinc Oxide Eugenol
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of Material, Tooth Shade, Resin
- All makers of Liner, Cavity, Calcium Hydroxide
- All makers of Syringe, Restorative And Impression Material
- All makers of Cement, Dental
Updated April 1, 2016. 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.