Coe Pak Auto Mix, Regular or Hard Set
FDA 510(k) K881422 · Coe Laboratories, Inc.
510(k) numberK881422
Submission
- Device name
- Coe Pak Auto Mix, Regular or Hard Set
- Applicant
- Coe Laboratories, Inc.
Alsip, IL, US - Received
- April 5, 1988
- Decision date
- October 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K252808 | GlasIonomer FX-LCEMA · Traditional | Shofu Dental Corporation | 12/09/2025SE |
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Questions and answers
When was Coe Pak Auto Mix, Regular or Hard Set cleared by the FDA?
Coe Pak Auto Mix, Regular or Hard Set (K881422) received a 510(k) decision of Substantially Equivalent on October 31, 1988, 209 days after the submission was received.
What is the product code of K881422?
The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.