Clearance Summary
ANSWER DENTAL IMPLEMENT, EXPLORER received FDA 510(k) clearance under submission number K894896, sponsored by Tern Chien Ent. Co., 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 1989-10-30.
- Submission: K894896
- Applicant / Sponsor: Tern Chien Ent. Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1989-10-30
Classification & Regulation
This clearance is catalogued under FDA product code EKJ and 21 CFR 872.4565, within the Dental review panel as a Class I device.