Resolut Regenerative Material
FDA 510(k) K970884 · W. L. Gore & Associates, Inc.
510(k) numberK970884
Submission
- Device name
- Resolut Regenerative Material
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- March 10, 1997
- Decision date
- May 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYC – Bone Grafting Material, Synthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
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| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
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Questions and answers
When was Resolut Regenerative Material cleared by the FDA?
Resolut Regenerative Material (K970884) received a 510(k) decision of Substantially Equivalent on May 8, 1997, 59 days after the submission was received.
What is the product code of K970884?
The FDA product code is LYC – Bone Grafting Material, Synthetic, a Class II (moderate risk) device regulated under 21 CFR 872.3930.