510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Pulpdent Corporation

Watertown, MA, US

PULPDENT CORPORATION appears in FDA device records in Watertown, MA. FDA records list 110 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
110
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 110

FDA records hold 110 510(k) clearances for Pulpdent Corporation between 1990 and 2021. The busiest year on record is 1990, with 17. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pulpdent Corporation, by decision year
YearClearances
199017
19916
19926
19937
19948
199513
19966
19974
19982
19991
20003
20011
200211
20034
20041
20061
20071
20081
20092
20102
20111
20127
20131
20161
20182
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K210045ACTIVA PRESTO PACKEBFSubstantially Equivalent
K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPDYHSubstantially Equivalent
K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPEBCSubstantially Equivalent
K153249Pulpdent Solo Flowable Composite with MCPEBFSubstantially Equivalent
K130223RMGI FILLEMASubstantially Equivalent
K123265RMGI LOW VISCOSITYEMASubstantially Equivalent
K120784TUFF-TEMP 2.0EBGSubstantially Equivalent
K120003NUCALEJKSubstantially Equivalent
K120213ETCH-RITE SUPREMEKLESubstantially Equivalent
K113818EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILLEBCSubstantially Equivalent
K113711LIME-LITE IIEJKSubstantially Equivalent
K113617SPEE-DEE PATCHEBFSubstantially Equivalent
K112946ACTIV VARNISHLBHSubstantially Equivalent
K100503PULPDENT COPAL VARNISH WITH FLUORIDELBHSubstantially Equivalent
K093620PULPDENT FLUORIDE VARNISHLBHSubstantially Equivalent
K090457ORALUBEONKSubstantially Equivalent
K090391PULPDENT MICRO-HYBRID COMPOSITEEBFSubstantially Equivalent
K081810PULPDENT TEMPORARY CROWN AND BRIDGE MATERIALEBGSubstantially Equivalent
K071278EMBRACE DUAL CURE COMPOSITE MATERIALSEBFSubstantially Equivalent
K052281EMBRACE WETBOND CLEAR SEALANTEBCSubstantially Equivalent
K040236PULPDENT VLC RESIN CEMENTEMASubstantially Equivalent
K032953EMBRACE WETBOND RESTORATION AND PFM REPAIR KITKLESubstantially Equivalent
K031915PULPDENT ETCH-RITE ROYALEKLESubstantially Equivalent
K031877EMBRACE WET-BOND RESTORATIVE MATERIALEBFSubstantially Equivalent
K030036TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENTDYHSubstantially Equivalent
K022492PULPDENT SEMI-GEL ETCHEBFSubstantially Equivalent
K022734PULPDENT CALCIUM HYDROXIDE PREPARATIONKIFSubstantially Equivalent
K022522PULPDENT PUTTY DAMEIESubstantially Equivalent
K020514PULPDENT GLAZE IIKLESubstantially Equivalent
K020481PULPDENT POST CEMENTEMASubstantially Equivalent
K020432PULPDENT GLAZEEBFSubstantially Equivalent
K020287DENTITION INTEGRATING MATERIALEBCSubstantially Equivalent
K014138PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENTDYHSubstantially Equivalent
K014133PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVEDYHSubstantially Equivalent
K020115PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEMDYHSubstantially Equivalent
K014059PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVEDYHSubstantially Equivalent
K013411PULPDENT CAVITY PREPARATION IVLBHSubstantially Equivalent
K994180PULPDENT CAVITY PREPARATION IIILBHSubstantially Equivalent
K994181PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDELBHSubstantially Equivalent
K994182PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDELBHSubstantially Equivalent
K993683PULPDENT UNO-DUOKLESubstantially Equivalent
K974202PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUSLBHSubstantially Equivalent
K974398PULPDENT CAVITY VARNISHLBHSubstantially Equivalent
K974014PULPDENT DENTASTIC UNOEMASubstantially Equivalent
K972445PULPDENT OX-OUTEMASubstantially Equivalent
K971594FLOW-RITEEBFSubstantially Equivalent
K964430PULPDENT SNOOPLFCSubstantially Equivalent
K963921PULPDENT SEAL-RITE UDMAEBCSubstantially Equivalent
K963652PULPDENT DESENSITIZEREBFSubstantially Equivalent
K962747PULPDENT ENDODONTIC POST CEMENT KITEMASubstantially Equivalent

Registered establishments

FDA registered establishments for Pulpdent Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12153051215305PULPDENT CORPORATION80 Oakland St, Watertown, MA 02472 US2026and 27 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Pulpdent Corporation edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain