510(k) K940785
K940785 is an FDA 510(k) premarket notification submitted by Worldwide Dental, Inc. for the device "MOUTH PROPS". The FDA issued a decision of Substantially Equivalent on October 5, 1994. The device falls under product code EIF (Accessories, Retractor, Dental), a Class I device regulated under 21 CFR 872.4565. Worldwide Dental, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1994
- Date Received
- February 22, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Retractor, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type