Coe-Sil
FDA 510(k) K792428 · Coe Laboratories, Inc.
510(k) numberK792428
Submission
- Device name
- Coe-Sil
- Applicant
- Coe Laboratories, Inc.
Mchenry, IL, US - Received
- November 27, 1979
- Decision date
- January 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDG – Kit, Earmold, Impression
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LDG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K823921 | Physicians Choice Silicone Ear PuttyLDG · Traditional | Santa Barbara Medco, Inc. | 03/28/1983SE |
More from Santa Barbara Medco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K903292 | Accuflex/Accumix Vinyl Poly Impression MaterialsELW · Traditional | 10/19/1990SE |
| K894282 | First Impression TMELW · Traditional | 12/22/1989SE |
| K894281 | First Impression with ChlorhexidineELW · Traditional | 09/26/1989SE |
| K891140 | Occlu-Seal(Tm) Visible Light-Cured Fissure SealantEBC · Traditional | 05/01/1989SE |
| K885010 | Tripton(Tm) Visible Light-Cured Univ. BondingKLE · Traditional | 02/13/1989SE |
| K881422 | Coe Pak Auto Mix, Regular or Hard SetEMA · Traditional | 10/31/1988SE |
| K881091 | Omnisil, Vinyl Polysiloxane Impression MaterialELW · Traditional | 06/28/1988SE |
| K863882 | Opalux Visible Light Cured Anterior CompositeEBF · Traditional | 11/18/1986SE |
| K842877 | Absolute Vinyl Polysiloxane ImpressELW · Traditional | 03/11/1985SE |
| K844325 | Coe-Lite Polymerization UnitEBZ · Traditional | 12/11/1984SE |
Questions and answers
When was Coe-Sil cleared by the FDA?
Coe-Sil (K792428) received a 510(k) decision of Substantially Equivalent on January 23, 1980, 57 days after the submission was received.
What is the product code of K792428?
The FDA product code is LDG – Kit, Earmold, Impression, a Class I (low risk) device regulated under 21 CFR 874.3300.