510(k) clearances

BruxZir® NOW SRC

Prismatik Dentalcraft, Inc. · Dental

K231940Substantially EquivalentTraditionalNHA
Open FDA's page for this record
Third party flag
N
City
Irvine
Advisory committee description
Dental
Address 1
2144 Michelson Dr.
Statement or summary
Summary
Product code
NHA
Zip code
92612
Applicant
Prismatik Dentalcraft, Inc.
Decision date
2024-05-15
Decision code
SESE
Country code
US
Device name
BruxZir® NOW SRC
Advisory committee
DE
Contact
So Hyun Park
K number
K231940
State
CA
Date received
2023-06-30
Review advisory committee
DE
Postal code
92612
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Abutment, Implant, Dental, Endosseous
Medical specialty description
Dental
Regulation number
872.3630
Device class
2
Registration number
1226544, 3023265483, 9613866, 3006973441, 3007362683, 3005730680, 3011587630, 1038806, 1424785, 3012635238, 3010860907, 2244842, 9613283, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3031162123, 8031058, 3030690317, 3009756327, 3007597023, 1036836, 3008088588, 3007135442, 3009727738, 3018077122, 3005554774, 3003402534, 3013465593, 2133778, 2530808, 3005503242, 3011649314, 3010303805, 3017450159, 3009514134 +342 more
FEI number
3023265483, 3006973441, 3007362683, 3005730680, 3011587630, 1038806, 3012635238, 3010860907, 2244842, 3005031178, 3007283751, 3011808221, 3023535580, 3012187973, 3036779616, 3004417597, 3031162123, 3030690317, 3007597023, 1036836, 3008088588, 3007135442, 3009727738, 3018077122, 3005554774, 3002768455, 3003402534, 3013465593, 3005503242, 1000272060, 3011649314, 3010303805, 3017450159, 3009514134, 3003394627, 3005597557, 3012205930, 3039641923, 3003024548, 3002807050 +342 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.