Clearance Summary
SHIELD, DENTAL X-RAY, PROTECTIVE received FDA 510(k) clearance under submission number K770407, sponsored by Worldwide Dental, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1977-03-15.
- Submission: K770407
- Applicant / Sponsor: Worldwide Dental, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.6500
- Decision date: 1977-03-15
Classification & Regulation
This clearance is catalogued under FDA product code IWO and 21 CFR 892.6500, within the Radiology review panel as a Class I device.