THERMAL PULP TESTER
FDA 510(k) clearance K940260 · decided 1994-03-07
Clearance details
- K-number
- K940260
- Device name
- THERMAL PULP TESTER
- Applicant
- Union Broach, Div. Moyco Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-01-21
- Decision date
- 1994-03-07
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- EAT
- Device class
- 2
- Regulation number
- 872.1720
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Philadelphia, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERMIQUE (K022097) | Parkell, Inc. | 2002-09-06 |
| ELEMENTS DIAGNOSTIC UNIT (K021298) | Sybron Endo/Analytic | 2002-06-19 |
| PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (K012427) | Specialites Septodont | 2001-10-09 |
| CHILLIT (K011666) | Heatshield, Inc. | 2001-08-06 |
| ENDO ANALYZER, MODEL 8005, MODIFIED (K990225) | Sybron Dental Specialties, Inc. | 1999-02-25 |
| ENDO ANALYZER, MODEL 8005 (K973439) | Sybron Dental Specialties, Inc. | 1997-12-08 |
| SYSTEM B HEAT SOURCE (K970715) | Sybron Dental Specialties, Inc. | 1997-04-07 |
| TOUCH N' HEAT (K963862) | Sybron Dental Specialties, Inc. | 1996-12-02 |
| ORTHO-ICE (K960799) | Ultimate Wireforms, Inc. | 1996-05-09 |
| DIGITEST (K950237) | Parkell, Inc. | 1995-06-09 |
| GENTAL PULSE (K950238) | Parkell, Inc. | 1995-05-09 |
| ENDO-ICE-PULP TESTER-THERMAL (K930764) | The Hygenic Corp. | 1993-05-27 |
Recalls involving this device
No recalls on record reference this clearance.