Medline Industries, Inc.
KIT OMF PED Dent Full Mouth RE
7manufacturers in China registered for this device type
287catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OFX |
| Device type | General Purpose Dental Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Premarket notification | Exempt |
| Record published | 2024-12-08 |
| Record revised | 2023-08-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 4, case of 3, case of 5, case of 6, case of 2, case of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJ87550A | In distribution | |
| DYNJ61390B | In distribution | |
| DYNJ80226B | In distribution | |
| MDSNV3ADA | In distribution | |
| DYNJ61726F | In distribution | |
| DYNJ82639 | In distribution | |
| DYNJ80644A | In distribution | |
| DYNJ908371C | In distribution | |
| DYNJ61727J | In distribution | |
| DYNJ910262 | In distribution | |
| DYNJ28232M | In distribution | |
| DYNJ906900C | In distribution | |
| DYNJ40065F | In distribution | |
| DYNJ16659N | In distribution | |
| DYNJ66446D | In distribution | |
| DYNJ0773916O | In distribution | |
| DYNJ37536C | In distribution | |
| DYNJ84952 | In distribution | |
| DYNJ65675A | In distribution | |
| DYKA1489 | In distribution | |
| DYNJ69261 | In distribution | |
| DYNJ903319K | In distribution | |
| DYNJ62779G | In distribution | |
| DYNJ906900D | In distribution | |
| DYNJ83057B | In distribution | |
| DYNJ81178 | In distribution | |
| DYNJ62261B | In distribution | |
| DYKM1827A | In distribution | |
| DYNJT4765 | In distribution | |
| DYNJ89285 | In distribution | |
| DYNJ17477G | In distribution | |
| DYNJ36724C | In distribution | |
| DYNJ52091C | In distribution | |
| DYNJ52404G | In distribution | |
| DYNJ907979C | In distribution | |
| DYNJ87909 | In distribution | |
| DYNJ16659L | In distribution | |
| DYNJ59407B | In distribution | |
| DYNJ16659O | In distribution | |
| DYNJ38877C | In distribution | |
| DYNJ39138I | In distribution | |
| DYNJ903882F | In distribution | |
| DYNJ89672 | In distribution | |
| DYNJ84533 | In distribution | |
| DYKA1511 | In distribution | |
| DYNJ68804B | In distribution | |
| DYKM1523A | In distribution | |
| DYNJ88388 | In distribution | |
| DYNJ65818A | In distribution | |
| DYNJ909451A | In distribution | |
| DYNJ56229A | In distribution | |
| DYNJ85851A | In distribution | |
| PHS41730C | In distribution | |
| DYNJ80452A | In distribution | |
| DYNJ909635C | In distribution | |
| DYNJ905540F | In distribution | |
| DYNJ903049K | In distribution | |
| DYNJ906941B | In distribution | |
| DYNJ61726B | In distribution | |
| DYNJ907979D | In distribution | |
| DYNJ80375 | In distribution | |
| DYNJ80616B | In distribution | |
| DYNJ80226D | In distribution | |
| DYNJ84952B | In distribution | |
| DYNJ16659M | In distribution | |
| DYNJ35979I | In distribution | |
| DYNJ80326 | In distribution | |
| DYNJ907856 | In distribution | |
| DYNJ56307B | In distribution | |
| DYNJ86470B | In distribution | |
| DYNJ49583D | In distribution | |
| DYNJ909211A | In distribution | |
| DYNJ64086B | In distribution | |
| DYNJ909211 | In distribution | |
| DYNJ52404D | In distribution | |
| DYNJ59073D | In distribution | |
| DYNJT4851 | In distribution | |
| DYNJ908371D | In distribution | |
| DYNJ59073B | In distribution | |
| DYNJ00095G | In distribution | |
| DYNJ88682A | In distribution | |
| DYNJ87488A | In distribution | |
| DYNJ909635 | In distribution | |
| DYNJ83140 | In distribution | |
| DYNJ83099A | In distribution | |
| DYNJ52091D | In distribution | |
| DYNJ908371B | In distribution | |
| DYNJ65818B | In distribution | |
| DYKMBNDL26B | In distribution | |
| DYNJ906900B | In distribution | |
| DYNJ62779D | In distribution | |
| DYKA1489A | In distribution | |
| DYKA1485A | In distribution | |
| DYNJ910808 | In distribution | |
| DYNJ910262A | In distribution | |
| DYNJ36723B | In distribution | |
| DYNJ83057 | In distribution | |
| DYNJ909801 | In distribution | |
| DYNJ49021G | In distribution | |
| DYNJ900281G | In distribution | |
| DYNJ84880A | In distribution | |
| DYNJ00354K | In distribution | |
| DYNJ62779I | In distribution | |
| DYNJ907979G | In distribution | |
| DYNJ58158A | In distribution | |
| DYNJ58157B | In distribution | |
| DYNJ41081D | In distribution | |
| DYNJ84952A | In distribution | |
| DYNJ0578762G | In distribution | |
| CDS980274K | In distribution | |
| DYNJ64198A | In distribution | |
| DYNJ903049I | In distribution | |
| DYNJ56307A | In distribution | |
| DYNJ0773916N | In distribution | |
| DYNJ66450A | In distribution | |
| DYNJ81438 | In distribution | |
| DYNJVB1359 | In distribution | |
| DYNJ87425 | In distribution | |
| DYNJ55481A | In distribution | |
| DYNJ66713B | In distribution | |
| DYNJ20491N | In distribution | |
| DYNJ908463A | In distribution | |
| DYNJ66446A | In distribution | |
| DYNJ28232N | In distribution | |
| DYNJ61727I | In distribution | |
| DYNJ906653B | In distribution | |
| DYNJ81438B | In distribution | |
| DYNJ83057A | In distribution | |
| DYNJ87550 | In distribution | |
| DYNJ903505B | In distribution | |
| DYNJ80226C | In distribution | |
| DYNJ80616 | In distribution | |
| DYNDA3065 | In distribution | |
| DYNJ0045920F | In distribution | |
| DYNJ907979B | In distribution | |
| DYNJ61726C | In distribution | |
| DYNJ49963F | In distribution | |
| DYNJ52404F | In distribution | |
| DYNJ49021F | In distribution | |
| DYNJ909635D | In distribution | |
| DYNJ52404I | In distribution | |
| DYNJ87624 | In distribution | |
| DYNJ54459C | In distribution | |
| DYNJ49963G | In distribution | |
| DYNJ86470A | In distribution | |
| DYNJ44984G | In distribution | |
| DYNJ49583F | In distribution | |
| DYNJ68804A | In distribution | |
| DYNJ65981B | In distribution | |
| CDS983103F | In distribution | |
| DYNJ88682 | In distribution | |
| DYKMBNDL26A | In distribution | |
| DYNJ80619A | In distribution | |
| DYNJ50873B | In distribution | |
| DYNDA2950 | In distribution | |
| DYNJ905551C | In distribution | |
| DYNJ81438A | In distribution | |
| DYKA1521 | In distribution | |
| DYNJ0045920D | In distribution | |
| DYNJ59941B | In distribution | |
| OST011F | In distribution | |
| DYNJ87773 | In distribution | |
| DYNJ907856A | In distribution | |
| DYNJ66713C | In distribution | |
| DYKA1485 | In distribution | |
| DYNJ904594I | In distribution | |
| DYNJ84585 | In distribution | |
| DYNJ84144 | In distribution | |
| CDS980199S | In distribution | |
| DYNJ25797F | In distribution | |
| DYNJ80616A | In distribution | |
| DYNJ89610 | In distribution | |
| DYNJ0773900N | In distribution | |
| DYNJ44954D | In distribution | |
| DYNJ83099 | In distribution | |
| DYNJ55481C | In distribution | |
| DYNJ58610F | In distribution | |
| DYNJ907979 | In distribution | |
| DYNJ84533C | In distribution | |
| DYNJ909801A | In distribution | |
| DYNJ909451 | In distribution | |
| DYNJ61041B | In distribution | |
| PHS807626F | In distribution | |
| DYNJ17477F | In distribution | |
| DYNJ81381A | In distribution | |
| DYNJ66450C | In distribution | |
| DYNJ68506C | In distribution | |
| DYNJ81438C | In distribution | |
| DYNJ907979F | In distribution | |
| DYNJ902179D | In distribution | |
| DYNJ58610G | In distribution | |
| DYNJ87488 | In distribution | |
| DYNJ58157A | In distribution | |
| CDS983010K | In distribution | |
| DYNJ906908A | In distribution | |
| DYNJ58341A | In distribution | |
| DYNJ65276A | In distribution | |
| DYNDA3082 | In distribution | |
| DYNJ903049C | In distribution | |
| DYNJ909284B | In distribution | |
| DYNJ51841C | In distribution | |
| DYNJ66446B | In distribution | |
| CDS983010J | In distribution | |
| DYNJ49329F | In distribution | |
| DYNJ81381 | In distribution | |
| DYKM2685 | In distribution | |
| DYNJ41929D | In distribution | |
| DYNJ84144A | In distribution | |
| DYNJ51841B | In distribution | |
| DYNJT3478 | In distribution | |
| DYNJ54807C | In distribution | |
| DYKA1512 | In distribution | |
| DYNJ62779F | In distribution | |
| DYNJ59919B | In distribution | |
| DYNJ66450B | In distribution | |
| DYNJ84880 | In distribution | |
| DYNJ38877B | In distribution | |
| DYNJ67866A | In distribution | |
| DYKM2096 | In distribution | |
| DYNJ83737 | In distribution | |
| DYNJ89672A | In distribution | |
| DYNJ904279D | In distribution | |
| DYNJ86470 | In distribution | |
| DYNJ910298A | In distribution | |
| DYNJ41963C | In distribution | |
| DYNJ45540D | In distribution | |
| DYNJ36233B | In distribution | |
| DYNJ66275A | In distribution | |
| DYNJ80221 | In distribution | |
| DYNJ61726D | In distribution | |
| DYNJ66450D | In distribution | |
| DYNJ80226 | In distribution | |
| DYNJ46247C | In distribution | |
| DYNDA3003 | In distribution | |
| DYNJ909284A | In distribution | |
| DYNJ67866B | In distribution | |
| DYNJ58610I | In distribution | |
| DYNJ89602 | In distribution | |
| DYNJ87157 | In distribution | |
| DYNJ909635B | In distribution | |
| DYNJ44984I | In distribution | |
| DYNJ904594G | In distribution | |
| DYKD100D | In distribution | |
| DYNJ44984J | In distribution | |
| DYNJ909635A | In distribution | |
| DYNJ61727L | In distribution | |
| DYKM2685A | In distribution | |
| DYNJ49021I | In distribution | |
| DYNJ39552D | In distribution | |
| DYNJ908371A | In distribution |
Showing 250 of 287 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 813 |
| Stradis Healthcare | Stradis Healthcare | 69 |
| Stradis | Stradis Healthcare | 44 |
| Aligned Medical Solutions | Aligned Medical Solutions | 25 |
| ACS | American Contract Systems, Inc. | 25 |
| Centurion | Centurion Medical Products Corporation | 21 |
| Medical Action Industries | Medical Action Industries, Inc. | 10 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| DeRoyal | Deroyal Industries, Inc. | 3 |
| Regard™ | ROi CPS LLC | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
Showing 12 of 46. All products under General Purpose Dental Tray
Recalls Naming This Product
10 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-03-19 | Class II | Under Investigation by firm | 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 endotoxin. | 2228 kits |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Under Investigation by firm | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 2236 units |
| Medline Industries, LP – Northfield | UDI-DI | 2026-01-07 | Class II | Process control | Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have | 3508 units |
| Medline Industries, LP – Northfield | UDI-DI | 2025-03-03 | Class II | Under Investigation by firm | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. | 573 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-10-09 | Class II | Under Investigation by firm | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. | 944 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-09-04 | Class II | Under Investigation by firm | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed. | 165 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-06-27 | Class II | Process control | Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suc | 19 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-03-22 | Class II | Under Investigation by firm | A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | 99 units |
| Medline Industries, LP – Northfield | UDI-DI | 2023-05-18 | Class II | Device Design | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. | 1130 units |
| Medline Industries, LP – Northfield | UDI-DI | 2022-11-17 | Class II | Device Design | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. | 174 cases (750 units) |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.