FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPLINT IT
K Number: K972985
·
Decision Sep 24, 1997
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
78
Review Days
44
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Basic Information
- Device Name
- SPLINT IT
- K Number
- K972985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jeneric/Pentron, Inc.
- Date Received
- August 11, 1997
- Decision Date
- September 24, 1997
- Product Code
- ELS
- 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 |
|---|---|---|---|
| ELS | Splint, Endodontic Stabilizing | FDA class 2 | Dental |
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ZEST ENDODONTIC STABILIZER
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Other Clearances by Jeneric/Pentron, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020499 | BOND-3 ADHESIVE | Apr 22, 2002 | Substantially Equivalent |
| K013543 | BOND-1 C & B | Feb 22, 2002 | Substantially Equivalent |
| K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | Feb 14, 2002 | Substantially Equivalent |
| K012231 | AVANTE MICRO CRYSTAL SYSTEM | Aug 23, 2001 | Substantially Equivalent |
| K011748 | FIRST FILL R.C.S. | Aug 3, 2001 | Substantially Equivalent |
| K010957 | QUELL DESENSITIZER | Jun 25, 2001 | Substantially Equivalent |
| K011330 | JP CAST 50 | Jun 22, 2001 | Substantially Equivalent |
| K011331 | JP CAST 40 | Jun 22, 2001 | Substantially Equivalent |
| K011362 | GOLD CORE 73 LS | May 29, 2001 | Substantially Equivalent |
| K010044 | COSMIC | Feb 9, 2001 | Substantially Equivalent |