FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GLENROE BAND SEATING CONTOURING INSTRUMENT
K Number: K924993
·
Decision Nov 25, 1992
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1
Applicant Total
8
Review Days
55
Basic Information
- Device Name
- GLENROE BAND SEATING CONTOURING INSTRUMENT
- K Number
- K924993
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GLENROE TECHNOLOGIES
- Date Received
- October 1, 1992
- Decision Date
- November 25, 1992
- Product Code
- ECS
- 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 |
|---|---|---|---|
| ECS | Pusher, Band, Orthodontic | FDA class 1 | Dental |
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| K924351 | GLENROE ELASTIBITE STIMULATOR | Jan 6, 1994 | Substantially Equivalent |
| K932920 | GLENROE PLASTIC BRACKET | Aug 24, 1993 | 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 |