Dental Barrier and Sleeves
FDA 510(k) clearance K233918 · decided 2024-05-09
Clearance details
- K-number
- K233918
- Device name
- Dental Barrier and Sleeves
- Applicant
- Yongqing Huaguan Dental Instruments Factory
- Decision
- Substantially Equivalent
- Date received
- 2023-12-13
- Decision date
- 2024-05-09
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- PEM
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Langfang, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.