FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
K Number: K912256
·
Decision Jul 24, 1991
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
29
Review Days
63
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Basic Information
- Device Name
- PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT
- K Number
- K912256
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lee Pharmaceuticals
- Date Received
- May 22, 1991
- Decision Date
- July 24, 1991
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by Lee Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K924378 | RESTOBOND 4 | Mar 31, 1993 | Substantially Equivalent |
| K900809 | LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS | Jun 28, 1990 | Substantially Equivalent |
| K894315 | RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT | Oct 31, 1989 | Substantially Equivalent |
| K881903 | PROSTHODENT VL | Jul 1, 1988 | Substantially Equivalent |
| K873123 | LEE COMPOSITE INLAY SYSTEM | Jan 20, 1988 | Substantially Equivalent |
| K863157 | RESTODENT POSTERIOR | Sep 25, 1986 | Substantially Equivalent |
| K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | Jan 30, 1986 | Substantially Equivalent |
| K844133 | CLEANSE N BOND I | Jan 4, 1985 | Substantially Equivalent |
| K844134 | CLEANSE N BOND II | Jan 4, 1985 | Substantially Equivalent |
| K843363 | RESTODENT VL | Oct 25, 1984 | Substantially Equivalent |