FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMZ - DENTAL IMPLANT O-RING ATTACHMENT
K Number: K951618
·
Decision Jul 26, 1995
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
12
Review Days
110
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Basic Information
- Device Name
- IMZ - DENTAL IMPLANT O-RING ATTACHMENT
- K Number
- K951618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imz, GmbH
- Date Received
- April 7, 1995
- Decision Date
- July 26, 1995
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Imz, GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K963520 | IMZ TWIN PLUS SCREW | Aug 12, 1997 | Substantially Equivalent |
| K963521 | IMZ TWIN PLUS - CYLINDER | Aug 6, 1997 | Substantially Equivalent |
| K963522 | IMZ 2000 INTERLOCK 12/3 - SCREW | Mar 3, 1997 | Substantially Equivalent |
| K963495 | IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM | Mar 3, 1997 | Substantially Equivalent |
| K951611 | IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENT | Aug 1, 1995 | Substantially Equivalent |
| K951609 | IMZ - DENTAL IMPLANT SURGICAL TRAY | Aug 1, 1995 | Substantially Equivalent |
| K951617 | IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENT | Jul 26, 1995 | Substantially Equivalent |
| K951615 | IMZ - DENTAL IMPLANT COMPONENTS | Jul 26, 1995 | Substantially Equivalent |
| K951612 | IMZ - DENTAL IMPLANT COMPONENTS | Jul 26, 1995 | Substantially Equivalent |
| K951610 | IMZ - DENTAL IMPLANT | Jul 26, 1995 | Substantially Equivalent |