Rotary Master
510(k) K992648
Rotary Master is a Class I device made by J. Morita U.S.A., Inc, cleared under FDA 510(k) K992648 on 31 Jan 2000, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992648 | Date31 Jan 2000 | StatusActive |
Official records
- FDA 510(k) database K992648
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBW
- FDA applicant
- J. Morita USA, Inc.
- Device class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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