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FDA 510(k)

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)

K-Number: K171161 · 2017-09-25

ApplicantDimensional Bioceramics, LLC
Decision Date2017-09-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is a medical device manufactured by Dimensional Bioceramics, LLC. It received FDA 510(k) clearance on 2017-09-25 under approval number K171161. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)?

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is a medical device that received FDA 510(k) clearance on 2017-09-25. It is manufactured by Dimensional Bioceramics, LLC. The 510(k) number is K171161.

When was Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) approved by the FDA?

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) received FDA 510(k) clearance on 2017-09-25, under approval number K171161.

What company makes Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)?

Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is manufactured by Dimensional Bioceramics, LLC.

What is the FDA product code for Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)?

The FDA product code for Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) is MQV.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07465549 CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension RECRUITING NCT06533397 The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation RECRUITING

Related PubMed Literature

PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

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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.

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