Legacy SMARTBase Abutments

FDA 510(k) K191458 · Implant Direct Sybron Manufacturing, LLC

Substantially Equivalent

510(k) numberK191458

Submission

Device name
Legacy SMARTBase Abutments
Applicant
Implant Direct Sybron Manufacturing, LLC
Thousand Oaks, CA, US
Received
May 31, 2019
Decision date
October 10, 2019
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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More from Hiossen, Inc.

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K202524Standard Sterilizable TrayKCT · Traditional 01/28/2021SE
K201553Simply Iconic ImplantsDZE · Traditional 01/22/2021SE
K200858Mini Sterilizable TrayKCT · Traditional 08/06/2020SE
K200265Surgical DrillsDZI · Traditional 06/30/2020SE
K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…DZE · Traditional 06/25/2020SE
K192218Custom Legacy and Custom InterActive Titanium AbutmentsNHA · Traditional 05/08/2020SE
K181359InterActive SMARTBase AbutmentsNHA · Traditional 08/15/2018SE

Questions and answers

When was Legacy SMARTBase Abutments cleared by the FDA?

Legacy SMARTBase Abutments (K191458) received a 510(k) decision of Substantially Equivalent on October 10, 2019, 132 days after the submission was received.

What is the product code of K191458?

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