Lip & Cheek Retractor
FDA 510(k) K771399 · L.D. Caulk Co.
510(k) numberK771399
Submission
- Device name
- Lip & Cheek Retractor
- Applicant
- L.D. Caulk Co.
Mchenry, IL, US - Received
- July 29, 1977
- Decision date
- August 26, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971284 | OpaldamEIG · Traditional | Ultradent Products, Inc. | 06/03/1997SE |
| K854711 | Fibrelight Illuminating Oral RetractorsEIG · Traditional | Downs Surgical , Ltd. | 02/25/1986SE |
| K832366 | Zoller Burned Lip ConformerEIG · Traditional | Universal Prosthetics, Inc. | 09/26/1983SE |
| K821784 | Beach Gingival Retraction Instr. Type BEIG · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K771973 | GingitractEIG · Traditional | Den-Mat Corp. | 11/07/1977SE |
| K761024 | Racestyptine RingsEIG · Traditional | Septodont, Inc. | 11/19/1976SE |
| K760657 | Racestyptine CordEIG · Traditional | Septodont, Inc. | 09/27/1976SE |
More from Septodont, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802262 | Composite Restorative · Traditional | 09/16/1980SESP |
| K801690 | ValiantEJJ · Traditional | 08/13/1980SE |
| K790586 | ChembondEMA · Traditional | 05/16/1979SE |
| K790585 | FinesseEBF · Traditional | 05/16/1979SE |
| K780560 | Dental AmalgamatorEFD · Traditional | 04/21/1978SE |
| K780384 | Improved DycalEJK · Traditional | 03/15/1978SE |
| K780301 | Caulk TylokEMA · Traditional | 02/28/1978SE |
| K771402 | Nuva-Cote (Modification to)EBC · Traditional | 08/26/1977SE |
| K771398 | Shell VeneerELM · Traditional | 08/26/1977SE |
| K771403 | Ease (Modification to)EJJ · Traditional | 08/22/1977SE |
Questions and answers
When was Lip & Cheek Retractor cleared by the FDA?
Lip & Cheek Retractor (K771399) received a 510(k) decision of Substantially Equivalent on August 26, 1977, 28 days after the submission was received.
What is the product code of K771399?
The FDA product code is EIG – Retractor, All Types, a Class I (low risk) device regulated under 21 CFR 872.4565.