FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACME COATED ORTHODONTIC ARCHWIRE
K Number: K895483
·
Decision Jan 29, 1990
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
5
Review Days
140
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
- ACME COATED ORTHODONTIC ARCHWIRE
- K Number
- K895483
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Acme-Monaco Corp.
- Date Received
- September 11, 1989
- Decision Date
- January 29, 1990
- Product Code
- EJF
- 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 |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJF), ordered by most recent decision date.
BITEM LOCK, MODELS SW006, SW012
FDA 510(k)
FDA Class 1
·Dental
MICROARCH GOLD BRACKET
FDA 510(k)
FDA Class 1
·Dental
ALASTIK
FDA 510(k)
FDA Class 1
·Dental
MEMORY WIRE
FDA 510(k)
FDA Class 1
·Dental
ORTHOTECH DURA-GOLD BARCKETS
FDA 510(k)
FDA Class 1
·Dental
FASCINATION CERAMIC BRACKET
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Acme-Monaco Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K113162 | SLIDEWIRETM(TRADEMARK PENDING) | Jul 20, 2012 | Substantially Equivalent |
| K920884 | GUIDEWIRES, VARIOUS TYPES | Aug 19, 1992 | Substantially Equivalent |
| K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | Apr 9, 1990 | Substantially Equivalent |
| K883763 | ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH | Nov 18, 1988 | Substantially Equivalent |