FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
V-DELTA, SF
K Number: K911537
·
Decision Apr 29, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
626
Applicant Total
67
Review Days
28
Basic Information
- Device Name
- V-DELTA, SF
- K Number
- K911537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- METALOR DENTAL USA CORP.
- Date Received
- April 1, 1991
- Decision Date
- April 29, 1991
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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Other Clearances by METALOR DENTAL USA CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K003387 | AUROFILM NP | Jan 9, 2001 | Substantially Equivalent |
| K993475 | AUROFLUID M, ALLOY NO. 5315 | Dec 9, 1999 | Substantially Equivalent |
| K993506 | PAGALINOR 4 , ALLOY NO. 5440 | Dec 8, 1999 | Substantially Equivalent |
| K993505 | V-DELTA SPECIAL, ALLOY NO. 5154 | Dec 8, 1999 | Substantially Equivalent |
| K993507 | V-SUPRAGOLD, ALLOY NO. 5024 | Dec 6, 1999 | Substantially Equivalent |
| K993508 | V-SUPRA PLUS, ALLOY NO. 5025 | Dec 6, 1999 | Substantially Equivalent |
| K993474 | DELTAPAL, ALLOY NO. 5161 | Dec 2, 1999 | Substantially Equivalent |
| K982606 | AUROFLUID CPF | Oct 15, 1998 | Substantially Equivalent |
| K973372 | AUROFILM 2000 | Nov 26, 1997 | Substantially Equivalent |
| K972683 | V-DELTA 450 | Aug 18, 1997 | Substantially Equivalent |