510(k) K970715
- Device
- SYSTEM B HEAT SOURCE
- Applicant
- SYBRON DENTAL SPECIALTIES, INC.
- 510(k) number
- K970715
- Product code
- EAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-07
- Date received
- 1997-02-27
- Regulation
- 872.1720
- Classification name
- Tester, Pulp
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN BOSWELL
- Address
- 1717 W. Collins Ave. Orange CA US 92867 92867
FDA Registration Numbers#
- 3008912871
- 1032227
- 3004425647
- 1937100
- 9680845
- 3005831677
- 3038718579
- 2411797
- 2086043
- 3018047916
- 3010864832
- 3008590661
- 2437780
- 3005581016
- 3004825240
- 3012494290
- 3012477813
- 3012421607
- 2024312
- 3000538043
- 2416455
Source Documents#
Other 510(k) Records For Product Code EAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022097 | THERMIQUE | Parkell, Inc. | 2002-09-06 |
| K021298 | ELEMENTS DIAGNOSTIC UNIT | Sybron Endo/Analytic | 2002-06-19 |
| K012427 | PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT | Specialites Septodont | 2001-10-09 |
| K011666 | CHILLIT | Heatshield, Inc. | 2001-08-06 |
| K990225 | ENDO ANALYZER, MODEL 8005, MODIFIED | Sybron Dental Specialties, Inc. | 1999-02-25 |
| K973439 | ENDO ANALYZER, MODEL 8005 | Sybron Dental Specialties, Inc. | 1997-12-08 |
| K963862 | TOUCH N' HEAT | Sybron Dental Specialties, Inc. | 1996-12-02 |
| K960799 | ORTHO-ICE | Ultimate Wireforms, Inc. | 1996-05-09 |
| K950237 | DIGITEST | Parkell, Inc. | 1995-06-09 |
| K950238 | GENTAL PULSE | Parkell, Inc. | 1995-05-09 |
| K940260 | THERMAL PULP TESTER | Union Broach, Div. Moyco Industries, Inc. | 1994-03-07 |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | The Hygenic Corp. | 1993-05-27 |
| K883804 | E-MITT (CONDUCTIVE HAND COVER) | The Institute For Technology Development | 1989-07-31 |
| K881826 | ENDO-ICE | The Hygenic Corp. | 1988-08-23 |
| K872039 | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS | Life-Tech Intl., Inc. | 1987-11-13 |
Legacy Summary#
summary
FDA Review#
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