FDA · official record K232049Substantially EquivalentIS-III active Short Implant
United StatesDZENeobiotech Co., Ltd.
Official record identity
- FDA application number
- K232049
- Decision date
- March 28, 2024
- Published decision
- Substantially Equivalent
Classification
Published parties
- Applicant
- Neobiotech Co., Ltd.
Additional source fields
- Decision code
- SESE
- Published decision
- Substantially Equivalent
- Submission type
- Traditional
- Received date
- 2023-07-10
- Review panel
- Dental
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 872.3640
About this record
This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.