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

Lancaster, PA, US

SEPTODONT appears in FDA device records in Lancaster, PA. FDA records list 20 510(k) clearances between and , no PMA records and 2 registered establishments. 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
20
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 20 510(k) clearances for Septodont between 1976 and 2021. The busiest year on record is 1976, with 7. The most recent is 2021, with 2.

Clearances by year, as a table
510(k) clearance decisions for Septodont, by decision year
YearClearances
19767
19772
19782
20031
20051
20071
20091
20101
20141
20181
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212283BioRoot Flow 0.5g, BioRoot Flow 2gKIFSubstantially Equivalent
K211799Biodentine XP 500, Biodentine XP 200KIFSubstantially Equivalent
K172839ENDOSOLVKIFSubstantially Equivalent
K140132BIODENTINEKIFSubstantially Equivalent
K093711RACEGELMVLSubstantially Equivalent
K092251BIODENTINEKIFSubstantially Equivalent
K063634RTR SYRINGELYCSubstantially Equivalent
K051010SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70EJJSubstantially Equivalent
K032708PLASTALGIN AND PLASTALGIN ORTHOELWSubstantially Equivalent
K780003ENDOSOLV EKJJSubstantially Equivalent
K771114NEUTROCIMEMASubstantially Equivalent
K761355SELFASTEMASubstantially Equivalent
K761354CIMPAT (PINK AND WHITE)EMASubstantially Equivalent
K760799FLUOCAL GEL ORANGESubstantially Equivalent
K760798FLUOCAL GEL MINTSubstantially Equivalent
K761024RACESTYPTINE RINGSEIGSubstantially Equivalent
K760660HYDROLLBHSubstantially Equivalent
K760659CALCIPULPEEJKSubstantially Equivalent
K760658DETARTRINE PEJRSubstantially Equivalent
K760657RACESTYPTINE CORDEIGSubstantially Equivalent

Registered establishments

FDA registered establishments for Septodont, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96109641000477999SEPTODONT58, RUE DU PONT DE CRETEIL, CEDEX Val-de-Marne 94107 FR2026
30082425643008242564Septodont, Inc205 Granite Run Dr., Suite 150, Lancaster, PA 17601 US2026

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