Pulp Pen
FDA 510(k) K873644 · The Hygenic Corp.
510(k) numberK873644
Submission
- Device name
- Pulp Pen
- Applicant
- The Hygenic Corp.
Akron, OH, US - Received
- September 9, 1987
- Decision date
- October 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K950237 | DigitestEAT · Traditional | Parkell, Inc. | 06/09/1995SE |
More from Parkell, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954990 | Dental DamEIE · Traditional | 01/26/1996SE |
| K930764 | Endo-Ice-Pulp Tester-ThermalEAT · Traditional | 05/27/1993SE |
| K905418 | Gates Glidden DrillsDZA · Traditional | 07/25/1991SE |
| K911225 | Tray DoughKGS · Traditional | 04/17/1991SE |
| K905640 | Solid Core Gutta Percha CarrierEKS · Traditional | 03/05/1991SE |
| K900301 | Novus Bonding AgentEBI · Traditional | 05/15/1990SE |
| K900844 | WedjetsEIE · Traditional | 04/16/1990SE |
| K894092 | Dental Endodontic Cement (Modification)KIF · Traditional | 01/10/1990SE |
| K881826 | Endo-IceEAT · Traditional | 08/23/1988SN |
| K863393 | EndocaterLQY · Traditional | 06/11/1987SE |
Questions and answers
When was Pulp Pen cleared by the FDA?
Pulp Pen (K873644) received a 510(k) decision of Substantially Equivalent on October 27, 1987, 48 days after the submission was received.
What is the product code of K873644?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.