CEREC Tessera Abutment System

FDA 510(k) K252248 · Dentsply Sirona

Substantially Equivalent

510(k) numberK252248

Submission

Device name
CEREC Tessera Abutment System
Applicant
Dentsply Sirona
York, PA, US
Received
July 18, 2025
Decision date
November 26, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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K251614Stainless Steel Surgical KitsKCT · Traditional 02/06/2026SE
K253959Primevision 3DOAS · Traditional 02/05/2026SE
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K252343Atlantis® Abutments in TitaniumNHA · Traditional 12/09/2025SE
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Questions and answers

When was CEREC Tessera Abutment System cleared by the FDA?

CEREC Tessera Abutment System (K252248) received a 510(k) decision of Substantially Equivalent on November 26, 2025, 131 days after the submission was received.

What is the product code of K252248?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.