FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CONVENTIONAL PLASTIC DENTAL TRAYS
K Number: K841491
·
Decision Jul 13, 1984
Classifications
1
FEI Numbers
317
Registration Numbers
317
Same Product Code
15
Applicant Total
11
Review Days
94
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Basic Information
- Device Name
- CONVENTIONAL PLASTIC DENTAL TRAYS
- K Number
- K841491
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Buffalo Dental Mfg. Co., Inc.
- Date Received
- April 10, 1984
- Decision Date
- July 13, 1984
- Product Code
- EHY
- 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 |
|---|---|---|---|
| EHY | Tray, Impression, Preformed | FDA class 1 | Dental |
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POST TRAY
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PREFORMED DENTAL IMPRESSION TRAYS
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CROWN INDEX TRAY
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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 |
| 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 |
| K820216 | ULTRA-WET | Feb 24, 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 |