DTE i-Scan
by Guilin Woodpecker Medical Instrument Co., Ltd.
DTE i-Scan is a medical device (FDA Class II; FDA product code MUH, System, X-Ray, Extraoral Source, Digital) made by Guilin Woodpecker Medical Instrument Co., Ltd., cleared under FDA 510(k) K212080 on 27 Sep 2021 and listed in FDA GUDID since 14 Oct 2021 (UDI-DI 06944843605647), 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 | GUDID listing | Number06944843605647 | Date14 Oct 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212080 | Date27 Sep 2021 | StatusActive |
Official records
- AccessGUDID record 06944843605647
- FDA 510(k) database K212080
Across registries
- FDA 510(k) K212080 decided 27 Sep 2021 Active
- FDA GUDID UDI-DI 06944843605647 listed 14 Oct 2021 Listed
Timeline
- Cleared FDA 510(k) K212080
- Listed FDA GUDID 06944843605647
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dte
- Generic name
- Dental computed radiography digital imaging scanner
- Model / reference
- i-Scan
- Primary DI / UDI-DI
- 06944843605647
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Dental computed radiography digital imaging scanner
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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