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

Placentia, CA, US

Handpiece Headquarters appears in FDA device records in Placentia, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Handpiece Headquarters between 2009 and 2024. The busiest year on record is 2009, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Handpiece Headquarters, by decision year
YearClearances
20091
20101
20141
20151
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243911HPR Cordless Hygiene HandpieceEKXSubstantially Equivalent
K233518BASE290 LED Curing LightEBZSubstantially Equivalent
K143183Maxima XTEND Handpiece Maintenance SystemEFBSubstantially Equivalent
K141125U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLEEGSSubstantially Equivalent
K100389HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENTEFBSubstantially Equivalent
K092053MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATHEGSSubstantially Equivalent

Registered establishments

FDA registered establishments for Handpiece Headquarters, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30070073573007007357Handpiece Headquarters - HPR Inc.620 S. Placentia Ave., Placentia, CA 92870 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0797-2019Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.Tip of the curing light was too hot causing a heat sensation in the patients.Class IIOpen, Classified

Verification record

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