510(k) clearances

AH Plus Endodontic Sealer

Dentsply Sirona, Inc. · Dental

K243546Substantially EquivalentTraditionalKIF
Open FDA's page for this record
Third party flag
N
City
York
Advisory committee description
Dental
Address 1
221 W. Philadelphia St.
Address 2
Suite 60w
Statement or summary
Summary
Product code
KIF
Zip code
17401
Applicant
Dentsply Sirona, Inc.
Decision date
2025-02-13
Decision code
SESE
Country code
US
Device name
AH Plus Endodontic Sealer
Advisory committee
DE
Contact
Rebecca Sporer
K number
K243546
State
PA
Date received
2024-11-15
Review advisory committee
DE
Postal code
17401
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Resin, Root Canal Filling
Medical specialty description
Dental
Regulation number
872.3820
Device class
2
Registration number
9615399, 3005831677, 3021971019, 3005628474, 3012187973, 9616142, 1410097, 8010908, 2436986, 2429849, 3012421607, 1413475, 3045857207, 3003120666, 9616128, 3011824442, 8010638, 1215305, 9680845, 1032227, 3023816720, 8020994, 3016447764, 3026400121, 3003449480, 3032312561, 2416455, 3013557697, 3004425647, 3004443427, 3008912871, 3012354669, 8010629, 3008822460, 3030405669, 8010468, 2320721, 3004748528, 3044819802, 8010414 +36 more
FEI number
3005831677, 3001180585, 3021971019, 3005628474, 3004586882, 3010138769, 3012187973, 1410097, 3002718942, 1000231788, 2429849, 3012421607, 1413475, 3045857207, 3003120666, 3011824442, 3000368601, 1215305, 3004724816, 1032227, 3026400121, 3023816720, 3016447764, 5615, 3003449480, 3002807929, 3032312561, 2416455, 3013557697, 1000554802, 3004425647, 3004443427, 3008912871, 3012354669, 3008822460, 3003667632, 3030405669, 3002574147, 3004748528, 3005907356 +36 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.