FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
SYNTEC DENTAL IMPLANT
K Number: K111189
·
Decision Dec 20, 2012
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
13
Review Days
602
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
- SYNTEC DENTAL IMPLANT
- K Number
- K111189
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntec Scientific Corp.
- Date Received
- April 28, 2011
- Decision Date
- December 20, 2012
- 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 Syntec Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K101971 | SYNTEC OS SPINAL FIXATION SYSTEM | Mar 25, 2011 | Substantially Equivalent |
| K092889 | SYNTEC OSTEO-PLATE AND SCREW FIXATION | Jun 25, 2010 | Substantially Equivalent |
| K090476 | SYNTEC ORTHODONTIC MINI SCREW | Jun 18, 2009 | Substantially Equivalent |
| K090839 | MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS | Apr 24, 2009 | Substantially Equivalent |
| K984602 | SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM | Mar 5, 1999 | Substantially Equivalent |
| K984364 | SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 | Mar 2, 1999 | Substantially Equivalent |
| K984543 | SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 | Mar 1, 1999 | Substantially Equivalent |
| K983988 | SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE | Jan 27, 1999 | Substantially Equivalent |
| K983873 | SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM | Dec 30, 1998 | Substantially Equivalent |
| K983495 | SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S 222020-248120, 240050-240980, 241130-246620, 4240420 | Dec 16, 1998 | Substantially Equivalent |