Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant Ha Coated , Refer to Table 1 in Sub
FDA 510(k) K981516 · Sterngold/Implamed
510(k) numberK981516
Submission
- Device name
- Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant Ha Coated , Refer to Table 1 in Sub
- Applicant
- Sterngold/Implamed
Attleboro, MA, US - Received
- April 28, 1998
- Decision date
- May 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
| K984341 | Sternvantage Varnish LC, Model 221001EBI · Traditional | 01/08/1999SE |
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| K983786 | Sterngold Implamed Wide Platform Dental Implants and Related Prosthetics and…DZE · Special | 11/13/1998SE |
| K982692 | Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LCEBF · Abbreviated | 10/22/1998SE |
| K982895 | Sternomega Compomer CementEMA · Traditional | 10/09/1998SE |
| K962326 | Sterngold BIO-5 (1127210)EJT · Traditional | 07/24/1996SE |
| K962325 | Quasar Yellow Crown and Bridge Alloy (1122015)EJT · Traditional | 07/24/1996SE |
| K962324 | Sterngold U-Cpf Metal Alloy (1067800)EJS · Traditional | 07/24/1996SE |
| K962304 | Sterngold BIO-4EJS · Traditional | 07/23/1996SE |
| K962303 | Sterngold CFEJT · Traditional | 07/18/1996SE |
Questions and answers
When was Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant Ha Coated , Refer to Table 1 in Sub cleared by the FDA?
Sterngold Implamed Hex Screw Implant TPS Coated Sterngold Implamed Hex Screw Implant Ha Coated , Refer to Table 1 in Sub (K981516) received a 510(k) decision of Substantially Equivalent on May 11, 1998, 13 days after the submission was received.
What is the product code of K981516?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.