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Panels › Dental › Product code OFX · Class 1

General Purpose Dental Tray

Regulation 872.6640

0510(k)s in 12 months (0 all time)
5recalls in 12 months (21 all time)
0recalls that name a 510(k)
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Top companies in OFX

DateFirm and productCodeLinked 510(k)
Sep 3, 2026Cardinal Health 200, LLC
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D
Open, Classified
OFXNone listed
Jun 17, 2026Medline Industries, LP
MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A
Open, Classified
OFXNone listed
May 7, 2026Medline Industries, LP
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Open, Classified
OFXNone listed
Apr 30, 2026Medline Industries, LP
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920
Open, Classified
OFXNone listed
Feb 17, 2026Medline Industries, LP
Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003
Open, Classified
OFXNone listed
Apr 17, 2025MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Model Number: DYNJ84880; 2) DENTAL PACK, Model Number: DYNJ56229A; 3) DENTAL PACK-LF, Model Number: PHS807626F; 4) DENTAL PA
Open, Classified
OFXNone listed
Feb 10, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Numb
Open, Classified
OFXNone listed
Jan 15, 2025Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Open, Classified
OFXNone listed
Dec 5, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Open, Classified
OFXNone listed
Oct 23, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline DENTAL PACK, REF DYNJ64086B; medical procedure convenience kit
Open, Classified
OFXNone listed
Sep 11, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline convenience kits containing semi-rigid suction liners labeled as follows: DENTAL, Pack Number DYNJ909451A
Open, Classified
OFXNone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010J ; 2) ORAL SURGERY PACK , Pack Number DYNJ00354K ; 3) ORAL PACK-LF, Pack Number DYNJ0426048L ; 4) ORAL SURG
Open, Classified
OFXNone listed
Aug 22, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
Open, Classified
OFXNone listed
Mar 29, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Open, Classified
OFXNone listed
Mar 29, 2024MEDLINE INDUSTRIES, LP - Northfield
Centurion STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6
Open, Classified
OFXNone listed
Aug 3, 2023MEDLINE INDUSTRIES, LP - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as STERILE SET FOR IMPLANT-LF, Model Number: OST011F.
Open, Classified
OFXNone listed
Jul 20, 2023MEDLINE INDUSTRIES, LP - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: STERILE SET FOR IMPLANT-LF, Model Number OST011F
Open, Classified
OFXNone listed
Feb 6, 2023MEDLINE INDUSTRIES, LP - Northfield
Sterile Procedural Trays, labeled as the following: a. ORAL SURGERY PACK-LF b. EXTRACTION PACK c. ORAL SURGERY PACK d. DENTAL MINOR PACK e. ORAL
Open, Classified
OFXNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
HENRY SCHEIN, OMFS, Item No.570-2779,
Open, Classified
OFXNone listed
Dec 14, 2022Stradis Medical, LLC dba Stradis Healthcare
STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
Open, Classified
OFXNone listed
Dec 11, 2019Centurion Medical Products Corporation
Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690
Terminated
OFXNone listed

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