FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL INSTRUMENTS - SCALERS
K Number: K823319
·
Decision Nov 24, 1982
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
6
Applicant Total
23
Review Days
16
Basic Information
- Device Name
- DENTAL INSTRUMENTS - SCALERS
- K Number
- K823319
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- MILTEX, INC.
- Date Received
- November 8, 1982
- Decision Date
- November 24, 1982
- Product Code
- EMS
- 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 |
|---|---|---|---|
| EMS | Curette, Periodontic | FDA class 1 | Dental |
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Other Clearances by MILTEX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K101653 | MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES | Aug 2, 2010 | Substantially Equivalent |
| K092855 | MILTEX MEMBRANE TACK KIT | Dec 29, 2009 | Substantially Equivalent |
| K083796 | MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT | Mar 9, 2009 | Substantially Equivalent |
| 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 |