Clearance Summary
THERMAFIL ENDODONTIC OBTURATOR received FDA 510(k) clearance under submission number K881139, sponsored by Tulsa Dental Products, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-04-07.
- Submission: K881139
- Applicant / Sponsor: Tulsa Dental Products, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3850
- Decision date: 1988-04-07
Classification & Regulation
This clearance is catalogued under FDA product code EKM and 21 CFR 872.3850, within the Dental review panel as a Class I device.