510(k) K980620
K980620 is an FDA 510(k) premarket notification submitted by Dentatus USA , Ltd. for the device "DENTATUS MTI MODULAR TRANSITIONAL IMPLANTS AND PROSTHETIC SYSTEM". The FDA issued a decision of Substantially Equivalent on May 15, 1998. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dentatus USA , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1998
- Date Received
- February 18, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type