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510(k) Data Aggregation
K Number
K211158Device Name
NTI ClenchGuard
Manufacturer
Boyd Research, Inc.
Date Cleared
2021-09-17
(151 days)
Product Code
OBR, MQC, OCO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Boyd Research, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. As an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing;
2. Protection against bruxism or nighttime teeth grinding and reduce damage and the noise associated with bruxing and/or grinding.
Device Description
Not Found
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K Number
K181005Device Name
ClenchGuard
Manufacturer
Boyd Research, Inc.
Date Cleared
2020-01-15
(639 days)
Product Code
OBR
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Boyd Research, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Protection against bruxism or nighttime teeth grinding.
- Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.
Device Description
Not Found
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