3M Clarity Aligners
FDA 510(k) K192119 · 3M Company
510(k) numberK192119
Submission
- Device name
- 3M Clarity Aligners
- Applicant
- 3M Company
Saint Paul, MN, US - Received
- August 6, 2019
- Decision date
- September 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code NXC
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| K260527 | FACE4D AlignerNXC · Traditional | Avinent Implant System S.L.U. | 07/02/2026SE |
| K260788 | Smylio AlignersNXC · Traditional | Smylio, Inc. | 05/08/2026SE |
| K260722 | SureSmile Aligner (ASSY500020)NXC · Traditional | Dentsply Sirona, Inc. | 04/15/2026SE |
| K253282 | ZSmile SystemNXC · Special | Dror Orthodesign , Ltd. | 02/03/2026SE |
| K251454 | Clear Aligner (SCF-3348)NXC · Traditional | Beame Medical Technology (Shenzhen) Limited | 01/07/2026SE |
| K250739 | Primeprint Direct AlignerNXC · Traditional | Dreve Dentamid GmbH | 11/07/2025SE |
| K252931 | Invisalign® Palatal Expander SystemNXC · Special | Align Technology, Inc. | 10/23/2025SE |
| K252870 | Invisalign Specifix Attachment SystemNXC · Special | Align Technology, Inc. | 10/09/2025SE |
| K251758 | Serafin®NXC · Traditional | Tns Co., Ltd. | 09/11/2025SE |
| K252380 | Invisalign SystemNXC · Special | Align Technology, Inc. | 08/29/2025SE |
More from Align Technology, Inc.
| 510(k) | Device | Decision |
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| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 01/28/2025SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Clarity Aligners cleared by the FDA?
3M Clarity Aligners (K192119) received a 510(k) decision of Substantially Equivalent on September 5, 2019, 30 days after the submission was received.
What is the product code of K192119?
The FDA product code is NXC – Aligner, Sequential, a Class II (moderate risk) device regulated under 21 CFR 872.5470.