Shell Veneer
FDA 510(k) K771398 · L.D. Caulk Co.
510(k) numberK771398
Submission
- Device name
- Shell Veneer
- 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)
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|---|---|---|---|
| K132984 | SR Vivodent S, SR Orthotyp S, SR Ortholingual SELM · Traditional | Ivoclar Vivadent, Inc. | 01/14/2014SE |
| K122955 | Dentavit, Monarch, Acrotone, Senator, DentoriumELM · Abbreviated | Wright Health Group , Ltd. | 03/01/2013SE |
| K122925 | New Stetic Artificial TeethELM · Traditional | New Stetic | 02/12/2013SE |
| K122852 | Physiostar NFCELM · Traditional | Candulor USA, Inc. | 12/06/2012SE |
| K121749 | VeraciaELM · Traditional | Shofu Dental Corporation | 09/07/2012SE |
| K120404 | Merz Dental GmbH Artegral HD Preformed Plastic Denture TeethELM · Traditional | Merz Dental GmbH | 05/21/2012SE |
| K120736 | SR Phonares IIELM · Traditional | Ivoclar Vivadent, AG | 05/14/2012SE |
| K113426 | Veracia SAELM · Traditional | Shofu Dental Corporation | 02/08/2012SE |
| K101064 | Bredent Novo.Lign A/ Bredent Novo.Lign PELM · Traditional | Bredent GmbH & Co. KG | 09/14/2010SE |
| K101029 | Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, Maist and Kaitong/Royal Synthetic Polymer TeethELM · Traditional | Huge Dental Material Co., Ltd. | 08/16/2010SE |
More from Huge Dental Material Co., Ltd.
| 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 |
| K771399 | Lip & Cheek RetractorEIG · Traditional | 08/26/1977SE |
| K771403 | Ease (Modification to)EJJ · Traditional | 08/22/1977SE |
Questions and answers
When was Shell Veneer cleared by the FDA?
Shell Veneer (K771398) 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 K771398?
The FDA product code is ELM – Denture, Plastic, Teeth, a Class II (moderate risk) device regulated under 21 CFR 872.3590.