Premier Dental Products Co.

• EMA — Dental4 devices
• KLE — Dental3 devices
• EBF — Dental2 devices
• EJR — Dental2 devices
• MVL — Unknown2 devices
• EBC — Dental1 device
• EBI — Dental1 device
• EHY — Dental1 device
• EKH — Dental1 device
• EKI — Dental1 device

• Z-1408-2025 — Premier Solo Diamond - Large Invented Cone; SKU: 807016C.Class II·Ongoing·2025-02-27

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K141839 — PREMIER ETCHCode KLE·2014-11-17
• K132526 — KNIT-PAK+Code MVL·2013-11-26
• K131212 — PREMIER CERAMIC PRIMERCode KLE·2013-08-26
• K083695 — TRAXODENTCode MVL·2009-04-28
• K062166 — ENAMEL PROCode EJR·2006-11-21
• K062683 — ENAMEL PRO VARNISHCode LBH·2006-11-21
• K061997 — PREMIER SELF-ETCHING ENAMEL SEALANTCode EBC·2006-10-04
• K061998 — PREMIER SELF-ETCHING BOND ENHANCERCode KLE·2006-10-04
• K051866 — PREMIER TEMPORARY CEMENTCode EMA·2005-09-06
• K042215 — RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENTCode EMA·2004-09-21
• K033309 — PREMIER IMPLANT CEMENT, MODEL 3001450Code EMA·2004-01-26
• K012160 — COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408Code EBF·2001-09-27
• K010195 — PREMIER ULTRASONIC SCALER AND INSERTSCode ELC·2001-04-17
• K970992 — PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUSCode GEH·1997-06-17
• K941856 — PREMIER PROMAX BITE GUARDCode JXL·1995-04-05
• K945395 — PREMIER MIRROR WARMERCode ETF·1995-01-18
• K923332 — ELECTROSURGICAL ELECTRODESCode GEI·1992-10-13
• K912149 — HARDCOATED PLASTIC FILLING INSTRUMENTCode EKJ·1991-06-24
• K891536 — ENAMEL MICROABRASION COMPOUNDCode EJR·1989-06-09
• K842295 — INTRAUTERINE DEVICE REMOVERCode HHF·1984-10-12
• K841011 — ELEVATOR - VARIOUSCode EMS·1984-06-15
• K841008 — BIOPSY PUNCH, VARIOUSCode GEE·1984-06-08
• K841005 — TONSIL KNIFE-VARIOUSCode KBQ·1984-05-30
• K841006 — EAR KNIFE-VARIOUSCode JYO·1984-05-30
• K841001 — EAR CURETTE, VARIOUSCode JYG·1984-05-29
• K841004 — SURGICAL CURETTE, VARIOUSCode HCY·1984-05-11
• K841002 — LACHRYMAL PROBES-VARIOUSCode HNW·1984-05-09
• K841007 — OPHTHALMIC CURETTE-VARIOUSCode HNZ·1984-05-09
• K841009 — SURGICAL RETRACTORS-VARIOUSCode GAD·1984-05-01
• K841010 — SURGICAL HOOKS, VARIOUSCode GDG·1984-05-01
• K841003 — PROBES, VARIOUSCode KOA·1984-03-20
• K800827 — PREMIER ABSORBENT POINTSCode EKN·1980-04-29
• K800900 — PREMIER TRIPLE TRAYCode EHY·1980-04-29
• K790325 — REPRODENTCode EBI·1979-03-02
• K782139 — ZYLOXCode ELW·1979-02-21
• K781034 — PREMIER INLAY PLACERCode EKI·1978-06-30
• K781035 — PERIODONTAL INSTRUMENT #21 GOLDMAN-FOXCode EMN·1978-06-30
• K780796 — ZYTRONCode EBF·1978-06-22
• K780528 — PREMIER CARVERS, STYLE #21C & 21DCode EKH·1978-04-19
• K771451 — SCUTABONDCode EMA·1977-08-16
• K771522 — FORCEPS, STYLE #849Code EMH·1977-08-16