Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

1Derful HS, 1Derful HT

K-Number: K210884 · 2021-07-27

Applicant1derful, Inc.
Decision Date2021-07-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

1Derful HS, 1Derful HT is a medical device manufactured by 1derful, Inc.. It received FDA 510(k) clearance on 2021-07-27 under approval number K210884. 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 1Derful HS, 1Derful HT?

1Derful HS, 1Derful HT is a medical device that received FDA 510(k) clearance on 2021-07-27. It is manufactured by 1derful, Inc.. The 510(k) number is K210884.

When was 1Derful HS, 1Derful HT approved by the FDA?

1Derful HS, 1Derful HT received FDA 510(k) clearance on 2021-07-27, under approval number K210884.

What company makes 1Derful HS, 1Derful HT?

1Derful HS, 1Derful HT is manufactured by 1derful, Inc..

What is the FDA product code for 1Derful HS, 1Derful HT?

The FDA product code for 1Derful HS, 1Derful HT is EIH.

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.

↑