Digital Doc
510(k) K981663
Digital Doc is a Class I device made by Digital Doc LLC, cleared under FDA 510(k) K981663 on 10 Aug 1998, active as of 22 Oct 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 | NumberK981663 | Date10 Aug 1998 | StatusActive |
Official records
- FDA 510(k) database K981663
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EIA
- FDA applicant
- Digital Doc, LLC
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6640
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K981663
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Iris X80 | IRIS-X80 / X80 | 00813557020144 | — | On the market |
| Iris X90 | IRIS-X90 / X90 | 00813557020205 | — | On the market |
| Iris-1000 | IRIS-1000 / Iris-1000 | 00813557020007 | — | On the market |
| PXL-1000 | PXL-1000 / PXL-1000 | 00813557020243 | — | On the market |
Similar devices
Other devices filed under FDA product code EIA (Unit, Operative Dental).
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- SureSmile Ortho Software 7.6 DIGI-500153 by ORAMETRIX, INC.