FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPER STRENGTH DENTURE ADHESIVE CREAM
K Number: K901938
·
Decision Jun 6, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
31
Applicant Total
5
Review Days
37
Basic Information
- Device Name
- SUPER STRENGTH DENTURE ADHESIVE CREAM
- K Number
- K901938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- TELEDYNE GETZ
- Date Received
- April 30, 1990
- Decision Date
- June 6, 1990
- Product Code
- KOB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KOB | Catheter, Suprapubic (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by TELEDYNE GETZ
| K Number | Device Name | ||
|---|---|---|---|
| K923675 | DENSPRO MEDIUM MINT PROPHY PASTE | Nov 5, 1992 | Substantially Equivalent |
| K923674 | DENSPRO COARSE MINT PROPHY PASTE | Nov 5, 1992 | Substantially Equivalent |
| K903568 | SUPER STRENGTH DENTURE ADHESIVE CREAM | Oct 24, 1990 | Substantially Equivalent |
| K901239 | TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE | May 15, 1990 | Substantially Equivalent |