FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BLL-FIL 6140 PARTICLES
K Number: K950511
·
Decision Apr 27, 1995
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
17
Review Days
80
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Basic Information
- Device Name
- BLL-FIL 6140 PARTICLES
- K Number
- K950511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Interfaces, Inc.
- Date Received
- February 6, 1995
- Decision Date
- April 27, 1995
- 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 Bio-Interfaces, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960164 | BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 | Apr 10, 1996 | Substantially Equivalent |
| K954763 | BIO-INTERFACES, INC,. BII-PLAST | Jan 4, 1996 | Substantially Equivalent |
| K950598 | BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT | Aug 23, 1995 | Substantially Equivalent |
| K950567 | BIO-APATITE 6140 HA PARTICLES | May 9, 1995 | Substantially Equivalent |
| K934049 | BII-PORE(TM) CANAL WALL PROSTHESIS | Jul 19, 1994 | Substantially Equivalent |
| K933688 | BII-PORE | Jul 19, 1994 | Substantially Equivalent |
| K941431 | BONE GRAFT DELIVERY SYRINGES | Jul 12, 1994 | Substantially Equivalent |
| K934430 | BON APATITE HA PARTICLES | May 18, 1994 | Substantially Equivalent |
| K934947 | BII-PLAST | Jan 26, 1994 | Substantially Equivalent |
| K924287 | 710 POROUS HA PARTICLES-BII-PORE | Apr 30, 1993 | Substantially Equivalent |