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Zest Anchors LLC

Carlsbad, CA, US

ZEST ANCHORS, LLC appears in FDA device records in Carlsbad, CA. FDA records list 26 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
26
PMA records
0
Recall records
3
Registered establishments
2

510(k) clearance history

FDA records hold 26 510(k) clearances for Zest Anchors LLC between 1980 and 2026. The busiest year on record is 1994, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Zest Anchors LLC, by decision year
YearClearances
19802
19841
19861
19881
19943
20001
20042
20071
20091
20121
20142
20151
20161
20191
20222
20241
20253
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260555LOCATOR® Angled AbutmentNHASubstantially Equivalent
K252944LOCATOR® Angled AbutmentNHASubstantially Equivalent
K250721LOCATOR® Angled AbutmentNHASubstantially Equivalent
K243272LOCATOR Angled AbutmentNHASubstantially Equivalent
K233587LOCATOR Angled Abutment (Various)NHASubstantially Equivalent
K220252High Retention Attachment SystemNHASubstantially Equivalent
K213391High Retention Attachment SystemNHASubstantially Equivalent
K191619TurboTemp EZEBGSubstantially Equivalent
K151789LOCATOR F-Tx Attachment SystemNHASubstantially Equivalent
K150295LOCATOR RTxNHASubstantially Equivalent
K133327SATURNO(TM) OVERDENTURE IMPLANT SYSTEMDZESubstantially Equivalent
K140570CHAIRSIDE ATTACHMENT PROCESSING MATERIALEBISubstantially Equivalent
K120198LOCATOR OVERDENTURE IMPLANT SYSTEMDZESubstantially Equivalent
K083324LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEMNHASubstantially Equivalent
K072878MODIFICATION TO: LOCATOR IMPLANT ANCHORNHASubstantially Equivalent
K042466X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALENHASubstantially Equivalent
K033699LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586DZESubstantially Equivalent
K994257LOCATOR IMPLANT ANCHORDZESubstantially Equivalent
K925849ZEST IMPLANT ANCHORDZESubstantially Equivalent
K934668ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)DZESubstantially Equivalent
K925700ZEST ANCHOR ADVANCED GENERATIONEGGSubstantially Equivalent
K882063MAGNE-DENT MAGNET/ZEST RETROFIT KEEPEREGGSubstantially Equivalent
K861561ZEST MARK II (STANDARD & MINI)EGGSubstantially Equivalent
K840244BIOCERAM ZEST PLANTDZESubstantially Equivalent
K801525ZEST ENDODONTIC STABILIZERELSSubstantially Equivalent
K801524ZEST PLANTDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Zest Anchors LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20239502023950ZEST ANCHORS, LLC2875 Loker Avenue East, Carlsbad, CA 92010 US2026and 19 more, listed in full below
30067962113006796211ZEST ANCHORS, LLC2230 Enterprise Street, Escondido, CA 92029 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2425-2020LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 .The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.Class IIOpen, Classified
Z-0935-2014LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878Zest Anchors, LLC is voluntarily recalling specific lots of LOCATOR Implant Attachment Systems because it is currently provided with a label that indicates that the final torque applied to the abutment should be 30 N-cm. It was recently noted by Zest that in order to provide an optimal performance by increasing the factor of safety between the failure load of the abutment screw and the recommendClass IITerminated
Z-0298-2009"LOCATOR Abutment for 5.7 Screw-Vent & Compatibles." Zest Anchors, Inc. Product is sold for use with any Zimmer Dental 5.7 mm diameter Tapered Screw-Vent Implant. The product is used with supra-gingival, universal hinge, resilient overdenture attachment for endosseous implants.The recall was initiated after the firm discovered through a customer complaint that the Locator Abutments for 5.7 Screw-vent & Compatibles do not fit properly in all sizes of the Zimmer Dental 5.7mm diameter Tapered Screw-Vent Implants (TSV6B8, TSV6B10, TSV6B11, TSV6B13, TSV6B16, TSV6H8, TSV6H10, TSV6H11, TSV6H13 and TSV6H16). The Locator Abutment bottoms out in the pilot hole of these implants cTerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain