FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLENROE PLASTIC BRACKET
K Number: K932920
·
Decision Aug 24, 1993
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
8
Review Days
70
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Basic Information
- Device Name
- GLENROE PLASTIC BRACKET
- K Number
- K932920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Glenroe Technologies
- Date Received
- June 15, 1993
- Decision Date
- August 24, 1993
- Product Code
- DYW
- 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 |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
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Other Clearances by Glenroe Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K980053 | GLENROE CHAIN | Feb 24, 1998 | Substantially Equivalent |
| K945535 | GLENROE ORTHO-SIL | Jan 27, 1995 | Substantially Equivalent |
| K924351 | GLENROE ELASTIBITE STIMULATOR | Jan 6, 1994 | Substantially Equivalent |
| K924140 | TUFF TIES | Apr 27, 1993 | Substantially Equivalent |
| K924139 | GLENROE ORTHO SEPS | Apr 8, 1993 | Substantially Equivalent |
| K924211 | EJECTOR | Mar 31, 1993 | Substantially Equivalent |
| K924993 | GLENROE BAND SEATING CONTOURING INSTRUMENT | Nov 25, 1992 | Substantially Equivalent |