FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA-WET
K Number: K820216
·
Decision Feb 24, 1982
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
11
Review Days
29
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Basic Information
- Device Name
- ULTRA-WET
- K Number
- K820216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Buffalo Dental Mfg. Co., Inc.
- Date Received
- January 26, 1982
- Decision Date
- February 24, 1982
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Buffalo Dental Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955573 | OPTIBLAST INTRAORAL SANDBLASTER | May 3, 1996 | Substantially Equivalent |
| K945220 | AMALGAM CARRIER | Jan 11, 1995 | Substantially Equivalent |
| K941954 | NON-FOGGING DENTAL MIRROR | Jul 8, 1994 | Substantially Equivalent |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Jul 13, 1984 | Substantially Equivalent |
| K841323 | FUZZY TRAY | Jun 27, 1984 | Substantially Equivalent |
| K841490 | POLYSULFIDE CUSTOM TRAY MATERIAL | Jun 27, 1984 | Substantially Equivalent |
| K820489 | ULTRAFINE TRAY ADHESIVE | Mar 19, 1982 | Substantially Equivalent |
| K802990 | ALGINATE/SILICONE CROWN & BRIDGE MATER | Feb 2, 1981 | Substantially Equivalent |
| K802882 | HYDROCOLLOID COMPATIBLE CREAM ALGINATE | Jan 28, 1981 | Substantially Equivalent |
| K802662 | POLYCARBONATE TEMPORARY CEMENT | Dec 16, 1980 | Substantially Equivalent |