FDA 510(k)

CEREC Guides

K-Number: K190059 · 2019-09-27

Decision Date2019-09-27

Product CodeNDP

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

CEREC Guides is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K190059. The device is classified under product code NDP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEREC Guides?

CEREC Guides is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Dentsply Sirona. The 510(k) number is K190059.

When did CEREC Guides receive FDA 510(k) clearance?

CEREC Guides received FDA 510(k) clearance on 2019-09-27, under 510(k) number K190059.

Who is the listed applicant for CEREC Guides?

The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEREC Guides?

The FDA product code for CEREC Guides is NDP.

Other records listing Dentsply Sirona as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260785DS Core CBCT Anatomy K260722SureSmile Aligner (ASSY500020)K253565SureSmile Software K251614Stainless Steel Surgical Kits K253959Primevision 3D K253009DS Core Detect

View all 86 devices →

Related Devices (Code: NDP)

K193405Simplant Digital GuideDentsply Sirona K170849SIMPLANT GuideDentsply Sirona

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.