FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Keystone Dental XL Dental Implant System
K Number: K201334
·
Decision Aug 18, 2020
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- Keystone Dental XL Dental Implant System
- K Number
- K201334
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Keystone Dental, Inc.
- Date Received
- May 20, 2020
- Decision Date
- August 18, 2020
- 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 Keystone Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240966 | Prima Plus Conical Implant System | Jul 9, 2024 | Substantially Equivalent |
| K223814 | Genesis ACTIVE Implant System | May 25, 2023 | Substantially Equivalent |
| K221381 | KDG Abutments | Aug 10, 2022 | Substantially Equivalent |
| K090397 | XPI ANGLED ABUTMENTS | Jun 5, 2009 | Substantially Equivalent |
| K071070 | OLYMPUS DENTAL IMPLANT SYSTEM | Oct 23, 2007 | Substantially Equivalent |
| K071599 | EASYGUIDE | Jul 11, 2007 | Substantially Equivalent |