PacTemp Automix NE
by The Belport Company, Inc. DBA Gingi-Pak
510(k) K261937
PacTemp Automix NE is a Class II device made by The Belport Company, Inc. DBA Gingi-Pak, cleared under FDA 510(k) K261937 on 7 Aug 2026, 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 | NumberK261937 | Date7 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K261937
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EMA
- FDA applicant
- The Belport Company Inc., DBA Gingi-Pak
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3275
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
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