Model 6110B Dentaphor
FDA 510(k) K870118 · Life-Tech Intl., Inc.
510(k) numberK870118
Submission
- Device name
- Model 6110B Dentaphor
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- January 12, 1987
- Decision date
- April 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Parkell, Inc.
| 510(k) | Device | Decision |
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| K954315 | PVC Abdominal/Rectal Pressure CatheterFEN · Traditional | 11/30/1995SE |
| K954341 | Urodynamics Tubing and Infusion SetsFEN · Traditional | 10/17/1995SE |
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| K953353 | Urovision JanusFEN · Traditional | 09/08/1995SE |
| K946108 | Ear-A-GatorKHH · Traditional | 06/13/1995SE |
| K913601 | MicrophorEGJ · Traditional | 07/15/1994SE |
| K940203 | Triple Lumen Urodynamic Catheter with Radiopaque MarkersFEN · Traditional | 03/30/1994SE |
Questions and answers
When was Model 6110B Dentaphor cleared by the FDA?
Model 6110B Dentaphor (K870118) received a 510(k) decision of Substantially Equivalent on April 10, 1987, 88 days after the submission was received.
What is the product code of K870118?
The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.