FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
K Number: K880322
·
Decision Jul 13, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
9
Applicant Total
9
Review Days
168
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Basic Information
- Device Name
- DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
- K Number
- K880322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6870
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Dentronix, Inc.
- Date Received
- January 27, 1988
- Decision Date
- July 13, 1988
- Product Code
- KMH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KMH | Sterilizer, Dry Heat | FDA class 2 | General Hospital |
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Other Clearances by Dentronix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910202 | DENTRONIX MODEL 2000 | Mar 13, 1991 | Substantially Equivalent |
| K771005 | NEW PODIATRY PRODUCTS | Jun 17, 1977 | Substantially Equivalent |
| K771006 | MODIFIED PODIATRY PRODUCTS | Jun 17, 1977 | Substantially Equivalent |
| K770304 | CUTTER, P605 GENERAL PURPOSE | Mar 9, 1977 | Substantially Equivalent |
| K770302 | CUTTER, P606 BONE | Mar 9, 1977 | Substantially Equivalent |
| K770303 | NIPPER, NAIL, P610 ENGLISH | Mar 9, 1977 | Substantially Equivalent |
| K770305 | CUTTER, P607 BONE | Mar 9, 1977 | Substantially Equivalent |
| K770301 | NIPPER, PSO4 TISSUE | Mar 7, 1977 | Substantially Equivalent |