Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
FDA 510(k) clearance K243777 · decided 2025-05-27
Clearance details
- K-number
- K243777
- Device name
- Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
- Applicant
- Theodent, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-12-09
- Decision date
- 2025-05-27
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- New Orleans, LA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Theodent
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.