Absorber, Saliva, Paper
Paper Saliva Absorber is a dental device, typically in the form of small absorbent paper or cotton rolls, used during dental procedures to absorb saliva from the oral cavity and maintain a dry working field, facilitating better access and adhesion for dental materials. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHR, regulated under 21 CFR 872.6050, within the Dental medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.
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Basic Information
- Product Code
- KHR
- Device Class
- FDA class 1
- Regulation Number
- 872.6050
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K980783 | SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 | Apr 21, 1998 | Substantially Equivalent | Irt Management Corp. |
| K954068 | GENERAL HYGIENE KIT | Nov 08, 1995 | Unknown | Physician Industries, Inc. |
| K953812 | GAUZE SPONGE | Oct 02, 1995 | Substantially Equivalent | Remington Medical, Inc. |
| K891054 | NON-STERILE GAUZE SPONGE | May 01, 1989 | Substantially Equivalent | Dispomed, Inc. |
| K891354 | ORTHODONTIC COTTON ROLL HOLDERS | Apr 17, 1989 | Substantially Equivalent | American Orthodontics |
| K890734 | DRY TIPS | Mar 10, 1989 | Substantially Equivalent | Microcopy, Div. Neo-Flo, Inc. |
| K870383 | ALGINATE WOOL FIBER | Apr 30, 1987 | Substantially Equivalent | Adri |
| K850988 | BOVO MOISTURE GUARD | Apr 16, 1985 | Substantially Equivalent | E.H. Medical Co. |
| K780400 | DEN-Z-ORB | Mar 27, 1978 | Substantially Equivalent | Nice-Pak Products, Inc. |
| K771908 | ISO-SHIELD SALIVA ABSORBERS | Nov 07, 1977 | Substantially Equivalent | 3M Company |
FEI Numbers
This FDA classification entry is associated with 148 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 148 registration numbers. Click on an entry to view related FDA registrations.