FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PERIO PIK
K Number: K840721
·
Decision Apr 25, 1984
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
10
Review Days
68
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
- PERIO PIK
- K Number
- K840721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Teledyne, Inc.
- Date Received
- February 17, 1984
- Decision Date
- April 25, 1984
- Product Code
- EFS
- 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 |
|---|---|---|---|
| EFS | Unit, Oral Irrigation | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFS), ordered by most recent decision date.
SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
FDA 510(k)
FDA Class 1
·Dental
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
FDA 510(k)
FDA Class 1
·Dental
AGATHA-A-H2010
FDA 510(k)
FDA Class 1
·Dental
DERMADAM
FDA 510(k)
FDA Class 1
·Dental
BARRIER ALL FILM
FDA 510(k)
FDA Class 1
·Dental
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
FDA 510(k)
FDA Class 1
·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 |
| K862695 | FLUOR-ETCH GEL ETCHANT | Jul 31, 1986 | Substantially Equivalent |
| K854817 | INSTAPURE | Feb 28, 1986 | 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 |