Dental: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

• 97device recalls (since 1 Jan 2023)
• 172510(k) clearances (since 1 Jan 2023)

Each number has its full source under its own list below.

• 29Jul2026

  General Purpose Dental Tray

  Reason: The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient,…

  Z-3099-2026
• 20Jul2026

  Amalgamator, Dental, Ac-Powered

  Reason: Potential for electrical discharge from unit when unplugged.

  Z-2954-2026
• 13Jul2026

  Abutment, Implant, Dental, Endosseous

  Reason: There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bo…

  Z-2929-2026
• 9Jul2026

  Material, Tooth Shade, Resin

  Reason: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.

  Z-3016-2026
• 30Jun2026

  Syringe, Irrigating (Non Dental)

  Reason: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or co…

  Z-2725-2026
• 8Jun2026

  Indirect Bonding Tray

  Reason: A product error defect may cause incorrect bracket placement.

  Z-2699-2026
• 4May2026

  General Purpose Dental Tray

  Reason: During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances…

  Z-2490-2026
• 27Mar2026

  Abutment, Implant, Dental, Endosseous

  Reason: Includes an incorrect screw seat interface.

  Z-1994-2026
• 27Mar2026

  Abutment, Implant, Dental, Endosseous

  Reason: Includes an incorrect screw seat interface.

  Z-1995-2026
• 19Mar2026

  General Purpose Dental Tray

  Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for…

  Z-2019-2026

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

• 30Oct2026

  Zirconia Collective 4y Dental Zirconia Blank

  Company: Zirconia Collective, Inc.

  K262685
• 29Oct2026

  Zirconia Dental Ceramics And Staining Solution

  Company: Fanen New Materials Technology (Suzhou) Co., Ltd.

  K262756
• 23Oct2026

  Mobile Dental Solution (model: Ds50, Ds70, Ds90)

  Company: Guangdong JINME Medical Technology Co., Ltd.

  K260275
• 22Oct2026

  Multineo Dental Implant System

  Company: Alpha Bio Tec , Ltd.

  K261295
• 1Oct2026

  Firstar Dental Handpieces

  Company: FDC Technology Industry Co.

  K260029
• 1Oct2026

  Firstar Dental Electric Motor

  Company: FDC Technology Industry Co.

  K260027
• 30Sep2026

  Dental Computed Tomography X-ray System (rubik Xsmart, Rubik X1, Rubik X3) (matrix 7000, Matrix 7800)

  Company: Fussen Technology Co., Ltd.

  K263033
• 18Sep2026

  Dental Diode Laser Device (laser-pen)

  Company: Guilin Kevin Peter Technology Co., Ltd.

  K261047
• 17Sep2026

  Triactive Dental Implant System

  Company: Paragon Implant Mfg., LLC

  K261392
• 14Sep2026

  Hand-held Dental X-ray System (hyperlight-m)

  Company: Changzhou Sifary Medical Technology Co., Ltd.

  K260795

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

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