510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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3M UNITEK Corporation

Monrovia, CA, US

3M UNITEK Corporation appears in FDA device records in Monrovia, CA. FDA records list 9 510(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
9
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for 3M UNITEK Corporation between 1995 and 2017. The busiest year on record is 2002, with 2. The most recent is 2017, with 1.

Clearances by year, as a table
510(k) clearance decisions for 3M UNITEK Corporation, by decision year
YearClearances
19951
20022
20061
20081
20101
20111
20121
20171
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K1636893M Clear Tray AlignerNXCSubstantially Equivalent
K113197APC FLASH-FREE ADHESIVEDYHSubstantially Equivalent
K102803CLARITY ADVANCED CERAMIC BRACKETSNJMSubstantially Equivalent
K100536TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVEDYHSubstantially Equivalent
K073697TRANSBOND SUPREME ADHESIVEDYHSubstantially Equivalent
K062305CLARITY MODIFIED CERAMIC BRACKETSNJMSubstantially Equivalent
K020394APC PLUS ADHESIVEDYHSubstantially Equivalent
K014142UNITE BONDING ADHESIVEDYHSubstantially Equivalent
K950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENTDYHSubstantially Equivalent

Registered establishments

FDA registered establishments for 3M UNITEK Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
202046720204673M UNITEK Corporation2724 SOUTH PECK RD., MONROVIA, CA 91016 US2026No device listings on this registration

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-0797-20253M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth.Due to an increase of complaints for bracket bond failures and skin irritation or blistering.Class IIOpen, Classified

Verification record

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