K260430
Substantially EquivalentPorcelain Etch Gel
Porcelain Etch Gel is exactly what the name says: a phosphoric-acid gel used in dental restorative procedures to condition tooth surfaces before adhesive bonding. Product code KLE covers dental etchants and bonding agents.
Dental panel, Traditional 510(k). KLE is a small, mature product code with a well-established predicate set — formulations vary minorly on viscosity, pH, and packaging. Clearances here are routine.
Belport Company / Gingi-Pak files from Camarillo, CA. Two-month review clock — among the fastest in our dataset, which is typical for low-complexity mature dental-materials categories like this.
- Applicant
- Belport Company, Inc., Gingi-Pak
- Product code
- KLE
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.