Flex-Star V
510(k) K072402
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK072402 | Date19 Oct 2007 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- FDA applicant
- Cmp Industries, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Flex-Star V is a dental device classified under Denture Relining, Repairing, or Rebasing Resin (Product Code: EBI), designed for the fabrication, repair, or rebasing of removable partial or full dentures, as well as occlusal splints and night guards. It is intended for use exclusively by licensed dental professionals in clinical settings to restore or modify denture bases using resin materials.
This device is supplied as a reusable system for dental laboratories and offices, requiring proper handling and storage per manufacturer guidelines. It is not sterile and must be cleaned and maintained according to dental practice protocols. The Flex-Star V holds an FDA 510(k) clearance (K072402) under the Traditional review pathway, with no third-party certification noted. Compliance with dental regulatory standards and manufacturer instructions ensures safe and effective use in denture fabrication procedures.
Other devices from Cmp Industries LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Flex-Star V used for?
The Flex-Star V is a dental device designed specifically for the fabrication, repair, or rebasing of removable partial or full dentures, as well as occlusal splints and night guards. It is intended exclusively for use by licensed dental professionals in clinical settings to restore or modify denture bases using resin materials.
Is the Flex-Star V reusable or single-use?
The Flex-Star V is supplied as a reusable system for dental laboratories and offices. It is not intended for single-use and requires proper cleaning and maintenance according to dental practice protocols to ensure safe and effective performance.
How should the Flex-Star V be stored?
The Flex-Star V must be stored and handled per the manufacturer’s guidelines to maintain its functionality. Since it is not sterile, it should be kept in a clean, dry environment and cleaned thoroughly after each use to prevent contamination and ensure compliance with dental regulatory standards.
Does the Flex-Star V come pre-sterilized?
No, the Flex-Star V is not sterile and must be cleaned and maintained according to dental practice protocols before and after each use. Sterility is not a feature of this device, as it is designed for reusable clinical applications.
What regulatory approval does the Flex-Star V hold?
The Flex-Star V holds FDA 510(k) clearance (K072402) under the Traditional review pathway, with a determination of substantial equivalence to a predicate device. This clearance is specific to its intended use in denture fabrication, repair, or rebasing procedures.