General Purpose Dental Tray

FDA product code OFX · Class I (low risk) · 21 CFR 872.6640 · Dental

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

0510(k) clearances
0PMA approvals
21recalls

Recalls

RecallProductFirmInitiated
Z-3099-2026 Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… Cardinal Health 200, LLC07/29/2026Open, Classified
Z-2490-2026 Class IIMEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit…During an internal review, Medline identified representative samples did not meet applicable performance… Medline Industries, LP05/04/2026Open, Classified
Z-2019-2026 Class IIMedline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1.…During an internal review, Medline identified higher-than-expected endotoxin levels on a representative… Medline Industries, LP03/19/2026Open, Classified
Z-2096-2026 Class IIMedline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1393-2026 Class IIMedline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003Medline has identified issues related to calibration of the equipment used to sterilize and package the… Medline Industries, LP01/07/2026Open, Classified
Z-1595-2025 Class IIMedline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number:…There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile… MEDLINE INDUSTRIES, LP - Northfield03/03/2025Open, Classified
Z-1130-2025 Class IICardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog…Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. Cardinal Health 200, LLC11/08/2024Open, Classified
Z-0911-2025 Class IICardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE…Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. Cardinal Health 200, LLC11/08/2024Open, Classified
Z-0628-2025 Class IIMEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL…Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil… MEDLINE INDUSTRIES, LP - Northfield10/09/2024Open, Classified
Z-0159-2025 Class IIMedline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kitIt has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may… MEDLINE INDUSTRIES, LP - Northfield09/04/2024Open, Classified
Z-3108-2024 Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows:…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… MEDLINE INDUSTRIES, LP - Northfield06/27/2024Open, Classified
Z-2999-2024 Class IIMedline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… MEDLINE INDUSTRIES, LP - Northfield04/08/2024Open, Classified
Z-2702-2024 Class IIMedline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. MEDLINE INDUSTRIES, LP - Northfield03/22/2024Open, Classified
Z-1431-2024 Class IICenturion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… MEDLINE INDUSTRIES, LP - Northfield02/23/2024Open, Classified
Z-1429-2024 Class IICenturion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… MEDLINE INDUSTRIES, LP - Northfield02/23/2024Open, Classified
Z-2171-2023 Class IIMedline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:…Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. MEDLINE INDUSTRIES, LP - Northfield05/18/2023Open, Classified
Z-2308-2023 Class IICustom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.…Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. MEDLINE INDUSTRIES, LP - Northfield05/15/2023Open, Classified
Z-1070-2023 Class IISterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b.…Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the… MEDLINE INDUSTRIES, LP - Northfield11/17/2022Open, Classified
Z-0515-2023 Class IIHENRY SCHEIN, OMFS, Item No.570-2779,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0493-2023 Class IISTRADIS HEALTHCARE, Implants, Item No.41015NSI, dental trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-1046-2020 Class IICenturion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690Incomplete seals on the sterile package may compromise the sterility Centurion Medical Products Corporation12/11/2019Terminated