FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBING SYRING
K Number: K854699
·
Decision Jan 6, 1986
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
11
Applicant Total
21
Review Days
46
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
- TUBING SYRING
- K Number
- K854699
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Almore Intl., Inc.
- Date Received
- November 21, 1985
- Decision Date
- January 6, 1986
- Product Code
- ECB
- 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 |
|---|---|---|---|
| ECB | Unit, Syringe, Air And/Or Water | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ECB), ordered by most recent decision date.
UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS
FDA 510(k)
FDA Class 1
·Dental
SURETIP SYRINGE TIP COVER
FDA 510(k)
FDA Class 1
·Dental
DENTAL SYRINGE TIP
FDA 510(k)
FDA Class 1
·Dental
RISKONTROL SINGLE USE
FDA 510(k)
FDA Class 1
·Dental
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE
FDA 510(k)
FDA Class 1
·Dental
SANI-TIP
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Almore Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862851 | ALMORE FACE MASK | Aug 12, 1986 | Substantially Equivalent |
| K854692 | MONARCH II BLEACHING INSTRUMENT | May 12, 1986 | Substantially Equivalent |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | Mar 26, 1986 | Substantially Equivalent |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Mar 25, 1986 | Substantially Equivalent |
| K854691 | DIAMOND BURS-HANDPIECE | Mar 25, 1986 | Substantially Equivalent |
| K854700 | EZ-ON TUBING CONDITIONER (LUBRICANT) | Mar 12, 1986 | Substantially Equivalent |
| K854702 | PLASTIC MOUNTING RINGS | Mar 6, 1986 | Substantially Equivalent |
| K854701 | RETRACT-A-CORD | Mar 6, 1986 | Substantially Equivalent |
| K854697 | TUBING HANDPIECE REPLACEMENT | Mar 6, 1986 | Substantially Equivalent |
| K831136 | DOUBLE BOW TOOTH SEPARATOR | Jun 8, 1983 | Substantially Equivalent |