DEVICE: DEKA SMARTPERIO (08057017760528)
Device Identifier (DI) Information
DEKA SMARTPERIO
M128A1
In Commercial Distribution
M128A1
EL.EN. SPA
M128A1
In Commercial Distribution
M128A1
EL.EN. SPA
The DEKA SmartPerio is a Nd:YAG laser device for soft tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip.
Device Characteristics
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47880 | Dental solid-state laser system |
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.
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FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GEX | Powered Laser Surgical Instrument |
| NVK | Laser, Dental, Soft Tissue |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K203396 | 000 |
| K213658 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 5 and 50 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Handling Environment Temperature: between 15 and 30 Degrees Celsius |
| Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
3b48e06b-2891-47d1-9b4c-a65b79c53daa
January 27, 2025
2
April 05, 2022
January 27, 2025
2
April 05, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined