FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS
K Number: K851714
·
Decision Jun 11, 1985
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
3
Applicant Total
79
Review Days
47
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Basic Information
- Device Name
- 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS
- K Number
- K851714
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Artiberia
- Date Received
- April 25, 1985
- Decision Date
- June 11, 1985
- Product Code
- EMM
- 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 |
|---|---|---|---|
| EMM | Chisel, Osteotome, Surgical | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMM), ordered by most recent decision date.
STERI-OSS SINUS AUGMENTATION KIT
FDA 510(k)
FDA Class 1
·Dental
CHISEL (OSTEOTOME, GOUGE, ETC.)
FDA 510(k)
FDA Class 1
·Dental
SURGICAL CHISEL
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Artiberia
| K Number | Device Name | ||
|---|---|---|---|
| K851745 | 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B | Aug 29, 1985 | Substantially Equivalent |
| K851786 | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF | Jul 9, 1985 | Substantially Equivalent |
| K851723 | 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS | Jul 2, 1985 | Substantially Equivalent |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | Jul 2, 1985 | Substantially Equivalent |
| K851722 | 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS | Jul 2, 1985 | Substantially Equivalent |
| K851720 | 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS | Jul 2, 1985 | Substantially Equivalent |
| K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | Jul 2, 1985 | Substantially Equivalent |
| K851718 | 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES | Jul 2, 1985 | Substantially Equivalent |
| K851719 | 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS | Jul 2, 1985 | Substantially Equivalent |
| K851724 | 1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS | Jul 2, 1985 | Substantially Equivalent |