Model 6110B Dentaphor
510(k) K870118
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870118 | Date10 Apr 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EAT
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.1720
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Model 6110B Dentaphor is an electrical pulp tester used to assess dental pulp vitality. It employs high-frequency current delivered via an electrode to stimulate nerve tissue within the tooth pulp, helping clinicians evaluate the responsiveness and health of dental pulp.
This device is intended for use in dental offices and is powered by either AC or battery. It is classified as a Class II medical device under FDA regulations (Product Code EAT) and holds a 510(k) clearance (K870118) dated April 10, 1987. The device is designed for single-use or reusable applications, depending on manufacturer guidelines, and requires proper storage to maintain functionality.