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FDA 510(k)

Perfit FS Dental Zirconia Fully Sintered Block

K-Number: K203590 · 2021-06-24

ApplicantVatech Acucera, Inc.
Decision Date2021-06-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Perfit FS Dental Zirconia Fully Sintered Block is a medical device manufactured by Vatech Acucera, Inc.. It received FDA 510(k) clearance on 2021-06-24 under approval number K203590. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perfit FS Dental Zirconia Fully Sintered Block?

Perfit FS Dental Zirconia Fully Sintered Block is a medical device that received FDA 510(k) clearance on 2021-06-24. It is manufactured by Vatech Acucera, Inc.. The 510(k) number is K203590.

When was Perfit FS Dental Zirconia Fully Sintered Block approved by the FDA?

Perfit FS Dental Zirconia Fully Sintered Block received FDA 510(k) clearance on 2021-06-24, under approval number K203590.

What company makes Perfit FS Dental Zirconia Fully Sintered Block?

Perfit FS Dental Zirconia Fully Sintered Block is manufactured by Vatech Acucera, Inc..

What is the FDA product code for Perfit FS Dental Zirconia Fully Sintered Block?

The FDA product code for Perfit FS Dental Zirconia Fully Sintered Block is EIH.

Related Clinical Trials

NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT07608406 Modified Versus Clear Twin Block for Skeletal Class II Malocclusion NOT_YET_RECRUITING NCT07560878 Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression RECRUITING NCT07571278 Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe NOT_YET_RECRUITING NCT07551024 Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla RECRUITING NCT07574099 Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla ACTIVE_NOT_RECRUITING

Other Devices by Vatech Acucera, Inc.

K203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank K203351Perfit ZR HT Dental Zirconia blank K222686Perfit FS Dental Zirconia Fully Sintered Block

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

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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