FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYGENIC RUBBER DAM LUBRICANT
K Number: K791970
·
Decision Nov 16, 1979
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
48
Applicant Total
16
Review Days
45
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HYGENIC RUBBER DAM LUBRICANT
- K Number
- K791970
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6375
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Hygenic Corp.
- Date Received
- October 2, 1979
- Decision Date
- November 16, 1979
- Product Code
- KMJ
- 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 |
|---|---|---|---|
| KMJ | Lubricant, Patient | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KMJ), ordered by most recent decision date.
Lubricating Jelly
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
COLONGLIDE(R) LUBRICANT
FDA 510(k)
FDA Class 1
·General Hospital
LUBE JELLY SURINGE
FDA 510(k)
FDA Class 1
·General Hospital
DUKAL LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by The Hygenic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954990 | DENTAL DAM | Jan 26, 1996 | Substantially Equivalent |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | May 27, 1993 | Substantially Equivalent |
| K905418 | GATES GLIDDEN DRILLS | Jul 25, 1991 | Substantially Equivalent |
| K911225 | TRAY DOUGH | Apr 17, 1991 | Substantially Equivalent |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | Mar 5, 1991 | Substantially Equivalent |
| K900301 | NOVUS BONDING AGENT | May 15, 1990 | Substantially Equivalent |
| K900844 | WEDJETS | Apr 16, 1990 | Substantially Equivalent |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | Jan 10, 1990 | Substantially Equivalent |
| K881826 | ENDO-ICE | Aug 23, 1988 | Substantially Equivalent for Some Indications |
| K873644 | PULP PEN | Oct 27, 1987 | Substantially Equivalent |