510(k) K801463
K801463 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "OJ-1 ENDODONIC ROOT CANAL FILE HOLDER". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code EKQ (Preparer, Root Canal Endodontic), a Class I device regulated under 21 CFR 872.4565. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1980
- Date Received
- June 24, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Preparer, Root Canal Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type