Digitest
FDA 510(k) K950237 · Parkell, Inc.
510(k) numberK950237
Submission
- Device name
- Digitest
- Applicant
- Parkell, Inc.
Farmingdale, NY, US - Received
- January 20, 1995
- Decision date
- June 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022097 | ThermiqueEAT · Traditional | Parkell, Inc. | 09/06/2002SE |
| K021298 | Elements Diagnostic UnitEAT · Traditional | Sybron Endo/Analytic | 06/19/2002SE |
| K012427 | Pharmaethyl Local Pulp and Vitality Testing AgentEAT · Traditional | Specialites Septodont | 10/09/2001SE |
| K011666 | ChillitEAT · Traditional | Heatshield, Inc. | 08/06/2001SE |
| K990225 | Endo Analyzer, Model 8005, ModifiedEAT · Traditional | Sybron Dental Specialties, Inc. | 02/25/1999SE |
| K973439 | Endo Analyzer, Model 8005EAT · Traditional | Sybron Dental Specialties, Inc. | 12/08/1997SE |
| K970715 | System B Heat SourceEAT · Traditional | Sybron Dental Specialties, Inc. | 04/07/1997SE |
| K963862 | Touch N' HeatEAT · Traditional | Sybron Dental Specialties, Inc. | 12/02/1996SE |
| K960799 | Ortho-IceEAT · Traditional | Ultimate Wireforms, Inc. | 05/09/1996SE |
| K950238 | Gental PulseEAT · Traditional | Parkell, Inc. | 05/09/1995SE |
More from Parkell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243254 | Parkell Pit and Fissure SealantEBC · Abbreviated | 08/08/2025SE |
| K210259 | Parkell Self-Adhesive CementEMA · Traditional | 01/20/2022SE |
| K191103 | Parkell Desensitizer GelEJK · Traditional | 11/22/2019SE |
| K190930 | SmarTemp X1EBG · Traditional | 09/05/2019SE |
| K182296 | HyperFil-LVEBF · Traditional | 12/14/2018SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | 11/21/2017SE |
| K151518 | Brush&Bond PlusKLE · Traditional | 09/18/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | 02/24/2015SE |
| K132115 | Absolute Dentin 2EBF · Traditional | 06/25/2014SE |
| K113839 | Retract Gingival Retraction/Hemostatic PasteMVL · Traditional | 04/12/2012SE |
Questions and answers
When was Digitest cleared by the FDA?
Digitest (K950237) received a 510(k) decision of Substantially Equivalent on June 9, 1995, 140 days after the submission was received.
What is the product code of K950237?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.