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

Irvine, CA, US

3M ESPE DENTAL PRODUCTS appears in FDA device records in Irvine, CA. FDA records list 12 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
12
PMA records
0
Recall records
2
Registered establishments
2

FDA records under these names

1 name

FDA records resolved to 3M ESPE Dental Products carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • 3M Company/3m Espe Dental Productsenforcement report, recall

510(k) clearance history

FDA records hold 12 510(k) clearances for 3M ESPE Dental Products between 2006 and 2023. The busiest year on record is 2011, with 2. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for 3M ESPE Dental Products, by decision year
YearClearances
20061
20071
20081
20101
20112
20121
20141
20192
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentLBHSubstantially Equivalent
K2302703M™ VitCal Liner/BaseEJKSubstantially Equivalent
K1911223M RelyX Pediatric Resin Modified Glass Ionomer CementEMASubstantially Equivalent
K1834763M Filtek Universal RestorativeEBFSubstantially Equivalent
K141081FILTEK BULK FILL POSTERIOR RESTROATIVEEBFSubstantially Equivalent
K120453FILTEK BULK FILL FLOWABLE RESTORATIVEEBFSubstantially Equivalent
K111185RELYX LUTING PLUS AUTOMIXEMASubstantially Equivalent
K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVEEBFSubstantially Equivalent
K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISHLBHSubstantially Equivalent
K073395GILB-2, GLASS IONOMER PROTECTIVE COATINGEMASubstantially Equivalent
K070956SEA2 SELF ETCH ADHESIVEKLESubstantially Equivalent
K062292UNICEMEMASubstantially Equivalent

Registered establishments

FDA registered establishments for 3M ESPE Dental Products, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
300517437030051743703M ESPE DENTAL PRODUCTS2510 Conway Ave., Saint Paul, MN 55144 US2026No device listings on this registration
202049320204933M ESPE Dental Products2111 McGaw Avenue, IRVINE, CA 92614 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-2100-20133M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.Class IITerminated
Z-0800-20073M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.Cement in 3M ESPE RelyX Veneer Cement Refill A3 Shade syringes, may not cure to the degree expected.Terminated

Verification record

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