FDA.report

510(k) K252248

Device
CEREC Tessera Abutment System
Applicant
Dentsply Sirona
510(k) number
K252248
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-26
Date received
2025-07-18
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Rebecca Sporer
Address
221 W. Philadelphia St. Suite 60w York PA US 17401 17401

FDA Registration Numbers

Source Documents

510(k) summary PDF

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