FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENHANCE
K Number: K861041
·
Decision May 30, 1986
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
13
Review Days
73
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
- ENHANCE
- K Number
- K861041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Packaging Technologies, Inc.
- Date Received
- March 18, 1986
- Decision Date
- May 30, 1986
- Product Code
- LYC
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYC), ordered by most recent decision date.
Bonalive Maxillofacial
FDA 510(k)
FDA Class 2
·Dental
BONTREE PLUS
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft M
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft B
FDA 510(k)
FDA Class 2
·Dental
Synthetic Bone Graft Particulate
FDA 510(k)
FDA Class 2
·Dental
CMFlexTM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Packaging Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K881756 | STERILE SURGEONS GLOVES | Jun 1, 1988 | Substantially Equivalent |
| K863326 | BONE MARROW TRAY | Sep 16, 1986 | Substantially Equivalent |
| K850544 | SHAVE PREP TRAY | Mar 12, 1985 | Substantially Equivalent |
| K850438 | RENAL BIOPSY TRAY | Feb 26, 1985 | Substantially Equivalent |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Jan 10, 1985 | Substantially Equivalent |
| K844611 | SINGLE BASIN SET | Dec 19, 1984 | Substantially Equivalent |
| K844614 | IV START KIT | Dec 19, 1984 | Substantially Equivalent |
| K844612 | ACUTE HEMODIALYSIS TRAYS | Dec 17, 1984 | Substantially Equivalent |
| K834074 | PERCUTANEOUS SHEATH INTRODUCER TRAY | Mar 19, 1984 | Substantially Equivalent |
| K834073 | CENTRAL VEIN CATHERIZATION TRAY CC-20 | Feb 28, 1984 | Substantially Equivalent |