FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENAMEL BOND SYSTEM
K Number: K790596
·
Decision Jun 15, 1979
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
129
Applicant Total
32
Review Days
81
Basic Information
- Device Name
- ENAMEL BOND SYSTEM
- K Number
- K790596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- WALLACE A. ERICKSON & CO.
- Date Received
- March 26, 1979
- Decision Date
- June 15, 1979
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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Other Clearances by WALLACE A. ERICKSON & CO.
| K Number | Device Name | ||
|---|---|---|---|
| K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | Feb 26, 1999 | Substantially Equivalent |
| K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | Dec 6, 1996 | Substantially Equivalent |
| K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | Jul 2, 1996 | Substantially Equivalent |
| K960365 | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) | Mar 28, 1996 | Substantially Equivalent |
| K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT | Mar 15, 1996 | Substantially Equivalent |
| K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL | Feb 21, 1996 | Substantially Equivalent |
| K955521 | ALPHA-DENT COPAL CAVITY VARNISH | Jan 24, 1996 | Substantially Equivalent |
| K955089 | ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT | Dec 13, 1995 | Substantially Equivalent |
| K942742 | ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV | Aug 29, 1994 | Substantially Equivalent |
| K942727 | ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADHESIVE | Aug 23, 1994 | Substantially Equivalent |