FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MOUTHGUARD AND ALIGNER MATERIALS
K Number: K062828
·
Decision Nov 27, 2006
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
12
Review Days
68
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MOUTHGUARD AND ALIGNER MATERIALS
- K Number
- K062828
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentsply Intl., Inc.
- Date Received
- September 20, 2006
- Decision Date
- November 27, 2006
- Product Code
- MQC
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQC), ordered by most recent decision date.
UltraPrint-Dental Hard Splint UV
FDA 510(k)
FDA Unclassified
·Unknown
Remvia NightGuard
FDA 510(k)
FDA Unclassified
·Unknown
NOBILCAM IMPAK Disc
FDA 510(k)
FDA Unclassified
·Unknown
Hard Splint & Thermo-Adaptive Splint
FDA 510(k)
FDA Unclassified
·Unknown
Remi Custom Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
LIJIA Night Guard
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Dentsply Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140347 | ANKYLOS C/X IMPLANT SYSTEM | Aug 20, 2014 | Substantially Equivalent |
| K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | Jul 23, 2013 | Substantially Equivalent |
| K103244 | QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION | Feb 14, 2011 | Substantially Equivalent |
| K093221 | PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II | Oct 30, 2009 | Substantially Equivalent |
| K083805 | ANKYLOS C/X DENTAL IMPLANT SYSTEM | May 22, 2009 | Substantially Equivalent |
| K082198 | DURASHIELD PLUS | Oct 29, 2008 | Substantially Equivalent |
| K072989 | AXIS SYSTEM | Jan 28, 2008 | Substantially Equivalent |
| K073117 | DENTIN DESENSITIZER AGENT | Dec 19, 2007 | Substantially Equivalent |
| K060836 | VISTADENT OC - VERSION 4 | Oct 27, 2006 | Substantially Equivalent |
| K053167 | BIOPURE MTAD ROOT CANAL CLEANSER | Dec 8, 2005 | Substantially Equivalent |