FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFE-T-PINS RETENTIVE PIN SYSTEM
K Number: K760723
·
Decision Oct 21, 1976
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
10
Applicant Total
53
Review Days
24
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
- SAFE-T-PINS RETENTIVE PIN SYSTEM
- K Number
- K760723
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Parkell, Inc.
- Date Received
- September 27, 1976
- Decision Date
- October 21, 1976
- Product Code
- EBL
- 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 |
|---|---|---|---|
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBL), ordered by most recent decision date.
CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
FDA 510(k)
FDA Class 1
·Dental
DENTAURUM JACKET CROWN & ROOT POSTS
FDA 510(k)
FDA Class 1
·Dental
ROOT CANAL POST
FDA 510(k)
FDA Class 1
·Dental
PROSTHETIC RESTORATION DEVICE
FDA 510(k)
FDA Class 1
·Dental
PLASTIC TOOTH REINFORCEMENT KIT
FDA 510(k)
FDA Class 1
·Dental
ELGILOY
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Parkell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243254 | Parkell Pit and Fissure Sealant | Aug 8, 2025 | Substantially Equivalent |
| K210259 | Parkell Self-Adhesive Cement | Jan 20, 2022 | Substantially Equivalent |
| K191103 | Parkell Desensitizer Gel | Nov 22, 2019 | Substantially Equivalent |
| K190930 | SmarTemp X1 | Sep 5, 2019 | Substantially Equivalent |
| K182296 | HyperFil-LV | Dec 14, 2018 | Substantially Equivalent |
| K172176 | Parkell Universal Adhesive | Nov 21, 2017 | Substantially Equivalent |
| K151518 | BRUSH&BOND PLUS | Sep 18, 2015 | Substantially Equivalent |
| K142848 | EAZY PRIMER | Feb 24, 2015 | Substantially Equivalent |
| K132115 | ABSOLUTE DENTIN 2 | Jun 25, 2014 | Substantially Equivalent |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Apr 12, 2012 | Substantially Equivalent |