FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEE-ALLOY DISPOSABLE CAPSULES
K Number: K780966
·
Decision Aug 21, 1978
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
3
Applicant Total
29
Review Days
70
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Basic Information
- Device Name
- LEE-ALLOY DISPOSABLE CAPSULES
- K Number
- K780966
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3110
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lee Pharmaceuticals
- Date Received
- June 12, 1978
- Decision Date
- August 21, 1978
- Product Code
- DZS
- 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 |
|---|---|---|---|
| DZS | Capsule, Dental, Amalgam | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZS), ordered by most recent decision date.
PRECAPSULED DENTAL AMALGAM
FDA 510(k)
FDA Class 1
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DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
FDA 510(k)
FDA Class 1
·Dental
MERCURY DISP. CAPSULE
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Lee Pharmaceuticals
| K Number | Device Name | ||
|---|---|---|---|
| K924378 | RESTOBOND 4 | Mar 31, 1993 | Substantially Equivalent |
| K912256 | PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT | Jul 24, 1991 | 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 |