FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
3I T3(R) EXTERNAL HEX DENTAL IMPLANTS
K Number: K133049
·
Decision Jan 8, 2014
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
12
Review Days
103
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS
- K Number
- K133049
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet 3i
- Date Received
- September 27, 2013
- Decision Date
- January 8, 2014
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
MegaGen Zygoma Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
INOSS System
FDA 510(k)
FDA Class 2
·Dental
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k)
FDA Class 2
·Dental
Adin Long Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ZENEX Implant System_Short (R-System)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Biomet 3i
| K Number | Device Name | ||
|---|---|---|---|
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | Jul 2, 2019 | Substantially Equivalent |
| K173374 | TSV BellaTek Encode Healing Abutments | Dec 13, 2017 | Substantially Equivalent |
| K170013 | Eztetic BellaTek Encode Healing Abutments | Sep 21, 2017 | Substantially Equivalent |
| K150571 | 3i T3 Short Implants | Nov 20, 2015 | Substantially Equivalent |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | Jul 30, 2013 | Substantially Equivalent |
| K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | Jun 21, 2013 | Substantially Equivalent |
| K122300 | T3 DENTAL IMPLANT | Jan 30, 2013 | Substantially Equivalent |
| K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | Sep 11, 2012 | Substantially Equivalent |
| K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | Jan 13, 2012 | Substantially Equivalent |
| K110449 | ENDOBON XENOGRAFT GRANULES | May 13, 2011 | Substantially Equivalent |