MOUTHGUARD AND ALIGNER MATERIALS

Mouthguard, Prescription

DENTSPLY INTL., INC.

The following data is part of a premarket notification filed by Dentsply Intl., Inc. with the FDA for Mouthguard And Aligner Materials.

Pre-market Notification Details

• Device ID: K062828
• 510k Number: K062828
• Device Name: MOUTHGUARD AND ALIGNER MATERIALS
• Classification: Mouthguard, Prescription
• Applicant: DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York, PA 17404
• Contact: Helen Lewis
• Correspondent: Helen Lewis; DENTSPLY INTL., INC. SUSQUEHANNA COMMERCE CENTER 221 W PHILADELPHIA ST. STE 60 York, PA 17404
• Product Code: MQC
• Subsequent Product Code: EBG
• Subsequent Product Code: KMY
• Subsequent Product Code: NXC
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-20
• Decision Date: 2006-11-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D7461AH20501	K062828	000
D7461A3251	K062828	000
D7461A320501	K062828	000
D7461A3201	K062828	000
D746135001	K062828	000
D746131251	K062828	000
D746131201	K062828	000
D746125001	K062828	000
D746121251	K062828	000
D746121201	K062828	000
D746115451	K062828	000
D746110811	K062828	000
D74611080251	K062828	000
D746110801	K062828	000
D746110611	K062828	000
D746110601	K062828	000
D7461A325501	K062828	000
D7461A325SH1	K062828	000
D7461A3471	K062828	000
D7461AH201	K062828	000
D7461A478501	K062828	000
D7461A4781	K062828	000
D7461A450SH1	K062828	000
D7461A450501	K062828	000
D7461A4501	K062828	000
D7461A425SH1	K062828	000
D7461A425501	K062828	000
D7461A4251	K062828	000
D7461A420501	K062828	000
D7461A4201	K062828	000
D7461A350SH1	K062828	000
D7461A350501	K062828	000
D7461A3501	K062828	000
D7461A347501	K062828	000
D74611041501	K062828	000
D746110411	K062828	000
D74610045501	K062828	000
D746100451	K062828	000
D746100401	K062828	000
D74610035SH1	K062828	000
D74610035501	K062828	000
D746100351	K062828	000
D746100301	K062828	000
D74610025SH1	K062828	000
D74610025501	K062828	000
D746100251	K062828	000
D746100201	K062828	000
D746100151	K062828	000
D746S2BSBG1	K062828	000
D746S2BS1	K062828	000
D746ACE040IP1	K062828	000
D74610045SH1	K062828	000
D746100601	K062828	000
D74610060251	K062828	000
D74611040SH1	K062828	000
D74611040501	K062828	000
D746110401	K062828	000
D746110311	K062828	000
D74611030SH1	K062828	000
D746110301	K062828	000
D746110211	K062828	000
D74611020SH1	K062828	000
D74611020501	K062828	000
D746110201	K062828	000
D746100851	K062828	000
D746100801	K062828	000
D74610065SH1	K062828	000
D74610065251	K062828	000
D746100651	K062828	000
D746ACE030IP1	K062828	000
D746IS25110801	K062828	000
D7461MEDL1251	K062828	000
D7461MEDL1201	K062828	000
D7461MEDL1	K062828	000
D7461M120CBK1	K062828	000
D7461M120C1	K062828	000
D7461E4781	K062828	000
D7461E3471	K062828	000
D7461E3251	K062828	000
D7461E3201	K062828	000
D7461E1201	K062828	000
D7461C500YE1	K062828	000
D7461C500TC1	K062828	000
D7461C500SH1	K062828	000
D7461C500RD1	K062828	000
D7461C500PLAS1	K062828	000
D7461MENL1	K062828	000
D74625110301	K062828	000
D74625110401	K062828	000
D746IS25110411	K062828	000
D746IS25110401	K062828	000
D746IS25110201	K062828	000
D746IS25191201	K062828	000
D746IS25135001	K062828	000
D746IS25131251	K062828	000
D746IS25110601	K062828	000
D746IS25110311	K062828	000
D746IS25110301	K062828	000
D746IS25100851	K062828	000
D746IS25100651	K062828	000
D746IS25100451	K062828	000
D746IS25100301	K062828	000
D746IS25100251	K062828	000
D74625325301	K062828	000
D7461C500OC1	K062828	000
D7461C500GR1	K062828	000
D7461APL40S51	K062828	000
D7461APL40S1251	K062828	000
D7461APL40C1251	K062828	000
D7461APL40C1201	K062828	000
D7461APL35S51	K062828	000
D7461APL35S1251	K062828	000
D7461APL35C1251	K062828	000
D7461APL35C1201	K062828	000
D7461AH50PLAS1	K062828	000
D7461AH50501	K062828	000
D7461AH501	K062828	000
D7461AH347501	K062828	000
D7461AH3471	K062828	000
D7461AH25SH1	K062828	000
D7461AH25501	K062828	000
D7461C1201	K062828	000
D7461C120501	K062828	000
D7461C1251	K062828	000
D7461C500BL1	K062828	000
D7461C500501	K062828	000
D7461C5001	K062828	000
D7461C478501	K062828	000
D7461C4781	K062828	000
D7461C135501	K062828	000
D7461C1351	K062828	000
D7461C125YE1	K062828	000
D7461C125TC1	K062828	000
D7461C125SH1	K062828	000
D7461C125RD1	K062828	000
D7461C125OC1	K062828	000
D7461C125GR1	K062828	000
D7461C125BL1	K062828	000
D7461C125501	K062828	000
D7461AH251	K062828	000