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

San Marcos, CA, US

SHOFU DENTAL CORP. appears in FDA device records in San Marcos, CA. FDA records list 97 510(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
97
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

Showing 50 of 97

FDA records hold 97 510(k) clearances for Shofu Dental Corp. between 1981 and 2025. The busiest year on record is 1983, with 6. The most recent is 2025, with 4.

Clearances by year, as a table
510(k) clearance decisions for Shofu Dental Corp., by decision year
YearClearances
19814
19836
19845
19852
19863
19872
19881
19891
19901
19912
19922
19941
19953
19973
19981
20001
20011
20021
20032
20042
20053
20072
20084
20103
20115
20125
20136
20152
20165
20174
20183
20192
20211
20223
20231
20254
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252808GlasIonomer FX-LCEMASubstantially Equivalent
K252165ZIRCONOMER PEMASubstantially Equivalent
K251470ResiCem EXEMASubstantially Equivalent
K251578BEAUTIFIL IIEBFSubstantially Equivalent
K233161BeautiLink SAEMASubstantially Equivalent
K222253GlasIonomer FX ULTRAEMASubstantially Equivalent
K213965BeautiBond XtremeKLESubstantially Equivalent
K212939Vintage Prime PressEIHSubstantially Equivalent
K200470Shofu Block HC HardEBFSubstantially Equivalent
K191794Vintage Art UniversalEIHSubstantially Equivalent
K182869Fit SAEBFSubstantially Equivalent
K181496VINTAGE PROEIHSubstantially Equivalent
K180803BeautiBond UniversalKLESubstantially Equivalent
K180649BeautiCem Veneer KitEBFSubstantially Equivalent
K172530BEAUTIFIL Flow Plus XEBFSubstantially Equivalent
K172106SHOFU MZ Primer PlusKLESubstantially Equivalent
K163568SHOFU RESIN GLAZEEBDSubstantially Equivalent
K162261CERAMAGE UPEBFSubstantially Equivalent
K161891HC PrimerKLESubstantially Equivalent
K160596BEAUTIFIL II LSEBFSubstantially Equivalent
K160086SHOFU Enamel ConditionerEBFSubstantially Equivalent
K151700BEAUTIFIL II GingivaEBFSubstantially Equivalent
K152392VINTAGE LDEIHSubstantially Equivalent
K152451VINTAGE Art LFEIHSubstantially Equivalent
K151699BEAUTIFIL II EnamelEBFSubstantially Equivalent
K132748BEAUTIFIL E POSTERIOR, BEAUTIFIL BULKEBFSubstantially Equivalent
K132141BEAUTIFIL BULK FLOWABLEEBFSubstantially Equivalent
K130841SHOFU BLOCK HCEBFSubstantially Equivalent
K131504UNIVERSAL OPAQUEEBFSubstantially Equivalent
K122614VINTAGE MP PRESS OVEREIHSubstantially Equivalent
K122908PRG BARRIER COATLBHSubstantially Equivalent
K123119CERARESIN BONDKLESubstantially Equivalent
K121749VERACIAELMSubstantially Equivalent
K120159BEAUTICEM SAEMASubstantially Equivalent
K112307RESIGLASS PASTEEMASubstantially Equivalent
K113426VERACIA SAELMSubstantially Equivalent
K111855HY-BOND RESIGLASSEMASubstantially Equivalent
K111782BEAUTISEALANTEBCSubstantially Equivalent
K111685IP TEMP CEMENTEMASubstantially Equivalent
K110252BEAUTIBOND MULTI PR PLUSKLESubstantially Equivalent
K110235BEAUTIBOND MULTIKLESubstantially Equivalent
K101621LITE ARTEBFSubstantially Equivalent
K101603BEAUTIFIL FLOW PLUSEBFSubstantially Equivalent
K093559VINTAGE MPEIHSubstantially Equivalent
K082744BEAUTIBONDKLESubstantially Equivalent
K080834VINTAGE ARTEIHSubstantially Equivalent
K080517RESICEMEMASubstantially Equivalent
K080068BEAUTIFIL OPAQUEREBFSubstantially Equivalent
K071742BEAUTIFIL IIEBFSubstantially Equivalent
K071452FL BOND IIKLESubstantially Equivalent

Registered establishments

FDA registered establishments for Shofu Dental Corp., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29167352916735SHOFU DENTAL CORP.1225 Stone Dr, SAN MARCOS, CA 92078 US2026and 9 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