FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRELUDE III TONGUE SUSPENSION SYSTEM
K Number: K110127
·
Decision Apr 8, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
9
Applicant Total
10
Review Days
80
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Basic Information
- Device Name
- PRELUDE III TONGUE SUSPENSION SYSTEM
- K Number
- K110127
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siesta Medical, Inc.
- Date Received
- January 18, 2011
- Decision Date
- April 8, 2011
- Product Code
- ORY
- 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 |
|---|---|---|---|
| ORY | Tongue Suspension System | FDA class 2 | Dental |
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Other Clearances by Siesta Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213159 | Encore System | Dec 22, 2021 | Substantially Equivalent |
| K201238 | Encore System | Oct 2, 2020 | Substantially Equivalent |
| K183310 | Encore System | May 9, 2019 | Substantially Equivalent |
| K133680 | ENCORE SYSTEM | Mar 26, 2014 | Substantially Equivalent |
| K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | Dec 6, 2012 | Substantially Equivalent |
| K121814 | ENCORE TONGUE SUSPENSION SYSTEM | Nov 7, 2012 | Substantially Equivalent |
| K111179 | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN | Jul 1, 2011 | Substantially Equivalent |
| K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | Jul 8, 2010 | Substantially Equivalent |