510(k) K182017
- Device
- Compex HD
- Applicant
- AdDent, Inc.
- 510(k) number
- K182017
- Product code
- QGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-29
- Date received
- 2018-07-27
- Regulation
- 872.6100
- Classification name
- Composite Resin Warmer
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joshua Friedman
- Address
- 43 Miry Brook Rd. Danbury CT US 06810 06810
FDA Registration Numbers#
- 3003694926
- 9611385
- 3005831677
- 2133714
- 8010908
- 3016891393
Source Documents#
Legacy Summary#
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FDA Review#
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