FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL INSTRUMENTS
K Number: K823314
·
Decision Nov 24, 1982
Classifications
1
FEI Numbers
264
Registration Numbers
264
Same Product Code
26
Applicant Total
23
Review Days
16
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Basic Information
- Device Name
- DENTAL INSTRUMENTS
- K Number
- K823314
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3240
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Miltex, Inc.
- Date Received
- November 8, 1982
- Decision Date
- November 24, 1982
- Product Code
- EJL
- 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 |
|---|---|---|---|
| EJL | Bur, Dental | FDA class 1 | Dental |
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|---|---|---|---|
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| K072563 | MILTEX RIGID CONTAINER SYSTEMS | Feb 12, 2008 | Substantially Equivalent |
| K061033 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS) | Dec 12, 2006 | Substantially Equivalent |
| K052018 | MILTEX LIGATING CLIP | Nov 4, 2005 | Substantially Equivalent |
| K050570 | MILTEX RIGID STERILIZATION CONTAINER SYSTEM | Jul 25, 2005 | Substantially Equivalent |
| K043013 | MILTEX LAPAROSCOPIC INSTRUMENTS | Mar 4, 2005 | Substantially Equivalent |
| K013888 | FIXATION (STEINMANN) PINS | May 1, 2002 | Substantially Equivalent |
| K954185 | RE-BAG MULTI-USE POUCH, LARGE & SMALL | Dec 4, 1995 | Unknown |