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

Brea, CA, US

PAC-DENT INC. appears in FDA device records in Brea, CA. FDA records list 8 510(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
8
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Pac-Dent Inc. between 2020 and 2022. The busiest year on record is 2021, with 5. The most recent is 2022, with 2.

Clearances by year, as a table
510(k) clearance decisions for Pac-Dent Inc., by decision year
YearClearances
20201
20215
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K202674Medidenta High Speed HandpiecesEFBSubstantially Equivalent
K202920OptiCompEBFSubstantially Equivalent
K202831The iMask Child's Face MaskOXZSubstantially Equivalent
K210189Pac-Dent Denture Base ResinEBISubstantially Equivalent
K210412Pac-Dent Ceramic Nanohybrid ResinEBFSubstantially Equivalent
K210186PacBond OneKLESubstantially Equivalent
K201182iMask Disposable Surgical Face MaskFXXSubstantially Equivalent
K200330RC-Prime Root Canal Preparation CreamKJJSubstantially Equivalent

Registered establishments

FDA registered establishments for Pac-Dent Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20860433000719964PAC-DENT INC.670 Endeavor Cir, Brea, CA 92821 US2026and 74 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.

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What MDM checks, and what it does not

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