FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GLENROE ORTHO-SIL
K Number: K945535
·
Decision Jan 27, 1995
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
24
Applicant Total
8
Review Days
74
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
- GLENROE ORTHO-SIL
- K Number
- K945535
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Glenroe Technologies
- Date Received
- November 14, 1994
- Decision Date
- January 27, 1995
- Product Code
- EGD
- 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGD), ordered by most recent decision date.
BRACE EZE
FDA 510(k)
FDA Class 1
·Dental
ORTHO WAX
FDA 510(k)
FDA Class 1
·Dental
BURNOUT MATERIAL
FDA 510(k)
FDA Class 1
·Dental
SALIVA-STIM
FDA 510(k)
FDA Class 1
·Dental
BITE RIM WAX
FDA 510(k)
FDA Class 1
·Dental
PALAVIT G
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Glenroe Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K980053 | GLENROE CHAIN | Feb 24, 1998 | Substantially Equivalent |
| 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 |
| K924993 | GLENROE BAND SEATING CONTOURING INSTRUMENT | Nov 25, 1992 | Substantially Equivalent |