510(k) K770117
K770117 is an FDA 510(k) premarket notification submitted by Hygienic Dental Mfg., Co., The for the device "HYGIENIC 5 & 6 RUBBER DAM FRAME". The FDA issued a decision of Substantially Equivalent on January 28, 1977. The device falls under product code EJE (Frame, Rubber Dam), a Class I device regulated under 21 CFR 872.6300. Hygienic Dental Mfg., Co., The has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 28, 1977
- Date Received
- January 21, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Frame, Rubber Dam
- Device Class
- Class I
- Regulation Number
- 872.6300
- Review Panel
- DE
- Submission Type