FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
K Number: K041324
·
Decision Jul 19, 2004
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
34
Review Days
62
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Basic Information
- Device Name
- CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER
- K Number
- K041324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lifecore Biomedical, Inc.
- Date Received
- May 18, 2004
- Decision Date
- July 19, 2004
- Product Code
- LYC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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Other Clearances by Lifecore Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | Nov 9, 2007 | Substantially Equivalent |
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | Oct 23, 2007 | Substantially Equivalent |
| K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | Oct 5, 2007 | Substantially Equivalent |
| K062876 | PRIMACONNEX CERAMIC ABUTMENTS | Nov 1, 2006 | Substantially Equivalent |
| K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | May 22, 2006 | Substantially Equivalent |
| K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | Jan 23, 2006 | Substantially Equivalent |
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS | Sep 9, 2005 | Substantially Equivalent |
| K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | Apr 15, 2005 | Substantially Equivalent |
| K032774 | RENOVA INTERNAL HEX IMPLANT SYSTEM | Nov 26, 2003 | Substantially Equivalent |