FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUOR-ETCH GEL ETCHANT
K Number: K862695
·
Decision Jul 31, 1986
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
10
Review Days
16
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
- FLUOR-ETCH GEL ETCHANT
- K Number
- K862695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Teledyne, Inc.
- Date Received
- July 15, 1986
- Decision Date
- July 31, 1986
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
BA Pit & Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Teledyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871828 | TED MODEL 760 | Feb 4, 1988 | Substantially Equivalent |
| K863131 | PIK POCKET (IRRIGATING TIP) | Aug 26, 1986 | Substantially Equivalent |
| K854817 | INSTAPURE | Feb 28, 1986 | Substantially Equivalent |
| K840721 | PERIO PIK | Apr 25, 1984 | Substantially Equivalent |
| K810864 | WATER PIK ORAL HYGIENE CENTER | Apr 21, 1981 | Substantially Equivalent |
| K810805 | WATER PIK AUTOMATIC TOOTHBRUSH | Apr 14, 1981 | Substantially Equivalent |
| K801593 | LEBODY BY WATER PIK | Aug 20, 1980 | Substantially Equivalent |
| K800919 | ORAVIEW BY WATER PIK | May 8, 1980 | Substantially Equivalent |
| K800448 | WATER PIK TRAVELER, MODEL 79 | Mar 5, 1980 | Substantially Equivalent |