FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
K Number: K852682
·
Decision Sep 23, 1985
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
21
Review Days
90
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Basic Information
- Device Name
- CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG
- K Number
- K852682
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Calcitek, Inc.
- Date Received
- June 25, 1985
- Decision Date
- September 23, 1985
- 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 Calcitek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962576 | SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM | Feb 10, 1997 | Substantially Equivalent |
| K962106 | SPLINE DENTAL IMPLANT SYSTEMS | Aug 29, 1996 | Substantially Equivalent |
| K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | Mar 8, 1996 | Substantially Equivalent |
| K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | Feb 8, 1996 | Substantially Equivalent |
| K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | Feb 8, 1996 | Substantially Equivalent |
| K946345 | INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM | Nov 15, 1995 | Substantially Equivalent |
| K946319 | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | Nov 15, 1995 | Substantially Equivalent |
| K946311 | INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | Oct 4, 1995 | Substantially Equivalent |
| K943180 | INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM | Sep 21, 1995 | Substantially Equivalent |
| K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | May 16, 1995 | Substantially Equivalent |