FDA UDI
In Commercial Distribution
🇺🇸 United States
MEGA ISQ II Instrument
DI: 09010522002674
·
Model: Osstell MEGA ISQ II Instrument
·
Osstell AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MEGA ISQ II Instrument
- Primary DI
- 09010522002674
- Version / Model
- Osstell MEGA ISQ II Instrument
- Catalog Number
- 103100
- Company Name
- Osstell AB
- Labeler DUNS
- 633171269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-09-26
- Public Version
- 1
- Public Version Date
- 2025-10-06
- Public Version Status
- New
- Public Device Record Key
- 68b6c306-d50a-4f9d-95d3-0deb01787907
Device Description
ISQ Measurement Instrument
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63467 | Dental implant stability resonance frequency analysis unit | An electrically-powered device designed to measure the stability of a dental implant by creating a noninvasive vibrational force and subsequently detecting the amount of movement in the implant [typically referred to as resonance frequency analysis (RFA)]. It is used with a disposable peg (not included) inserted into the implant or abutment, and consists of electronics to create an electromagnetic pulsation to vibrate the peg, a monitor, controls and a probe. This measurement can be repeated over time to assess the progress of implant osseointegration. It may be supplied with accessories such as mounts and test pegs. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 09010522002667 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 09010522002674 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181888 | 000 |