510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Parkell, Inc.

Edgewood, NY, US

PARKELL, INC. appears in FDA device records in Edgewood, NY. FDA records list 61 510(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
61
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 61

FDA records hold 61 510(k) clearances for Parkell, Inc. between 1976 and 2025. The busiest year on record is 1995, with 9. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Parkell, Inc., by decision year
YearClearances
19761
19801
19851
19881
19893
19902
19911
19921
19931
19941
19959
19963
19974
19984
19992
20002
20012
20022
20032
20041
20064
20082
20101
20121
20141
20152
20171
20181
20192
20221
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243254Parkell Pit and Fissure SealantEBCSubstantially Equivalent
K210259Parkell Self-Adhesive CementEMASubstantially Equivalent
K191103Parkell Desensitizer GelEJKSubstantially Equivalent
K190930SmarTemp X1EBGSubstantially Equivalent
K182296HyperFil-LVEBFSubstantially Equivalent
K172176Parkell Universal AdhesiveKLESubstantially Equivalent
K151518BRUSH&BOND PLUSKLESubstantially Equivalent
K142848EAZY PRIMERKLESubstantially Equivalent
K132115ABSOLUTE DENTIN 2EBFSubstantially Equivalent
K113839RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTEMVLSubstantially Equivalent
K101044RETRIEVE IMPLANT CEMENTEMASubstantially Equivalent
K080549DURAFINISH ALL-CURE, MODEL S296EBDSubstantially Equivalent
K073698SECUREEMASubstantially Equivalent
K062518CELERITYEBFSubstantially Equivalent
K063003AURORAEBZSubstantially Equivalent
K060946CZ-S2000KIFSubstantially Equivalent
K053516MUCOHARDEBISubstantially Equivalent
K040599PARKELL RESIN GLAZEEBDSubstantially Equivalent
K032179COMP. EKLESubstantially Equivalent
K031212TEMPORARY RESIN CEMENTEMASubstantially Equivalent
K022097THERMIQUEEATSubstantially Equivalent
K020239TOUCH&BOND-PLUSKLESubstantially Equivalent
K012360LC TEMPORARY FILLINGEBGSubstantially Equivalent
K010475D/C CORE MATERIALEBFSubstantially Equivalent
K002195FORAMATRON V, MODEL D680LQYSubstantially Equivalent
K994302RESIN TOOTH BONDING AGENTKLESubstantially Equivalent
K991270SMARTEMPEBGSubstantially Equivalent
K990381TOTALBONDEMASubstantially Equivalent
K983413MODEL MS-1 HANDPIECEEKXSubstantially Equivalent
K982050MODEL MS-2 HANDPIECEEFBSubstantially Equivalent
K974865CSREBISubstantially Equivalent
K973679AEROETCHERKOJSubstantially Equivalent
K973976EPIC-FLOEBFSubstantially Equivalent
K973200CARIES STAINLFCSubstantially Equivalent
K972421EASY BONDKLESubstantially Equivalent
K964867HYBRID RESIN COMPOSITEKLESubstantially Equivalent
K962741TRI-PHASIX CHROMATIC ALGINATEELWSubstantially Equivalent
K960879AMALGAMIBOND PLUSKLESubstantially Equivalent
K960464C & B METABOND (MODIFICATION)EMASubstantially Equivalent
K952124ABONDKLESubstantially Equivalent
K952123MS EMULSIONKLESubstantially Equivalent
K950237DIGITESTEATSubstantially Equivalent
K950239SENSIMATIC 500SEEKZSubstantially Equivalent
K950238GENTAL PULSEEATSubstantially Equivalent
K950857FORAMATRON IVLQYSubstantially Equivalent
K950905C&B-METABOND RADIOPAQUE POWDERKLESubstantially Equivalent
K950256TURBO 25/30ELCSubstantially Equivalent
K950240LE CLEAN MACHINEELCSubstantially Equivalent
K942017V-PRIMERKLESubstantially Equivalent
K933547INTRA-ORAL IRRIGATORELCSubstantially Equivalent

Registered establishments

FDA registered establishments for Parkell, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
24117972411797PARKELL, INC.300 EXECUTIVE DR., EDGEWOOD, NY 11717 US2026and 20 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

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