Endo-Ice
FDA 510(k) K881826 · The Hygenic Corp.
510(k) numberK881826
Submission
- Device name
- Endo-Ice
- Applicant
- The Hygenic Corp.
Akron, OH, US - Received
- April 29, 1988
- Decision date
- August 23, 1988
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
| K873644 | Pulp PenEAT · Traditional | 10/27/1987SE |
| K863393 | EndocaterLQY · Traditional | 06/11/1987SE |
Questions and answers
When was Endo-Ice cleared by the FDA?
Endo-Ice (K881826) received a 510(k) decision of Substantially Equivalent for Some Indications on August 23, 1988, 116 days after the submission was received.
What is the product code of K881826?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.