FDA 510(k) K073652, ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE, by Nakamura Magnifier Co., Ltd.
FDA 510(k) K073652, ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE, by Nakamura Magnifier Co., Ltd.
FDA 510(k) records for ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE (K073652), submitted by Nakamura Magnifier Co., Ltd..
- 510(k) Number: K073652
- Device Classification: Handpiece, Air-Powered, Dental
- Applicant: Nakamura Magnifier Co., Ltd.
- Date Received: 12/26/2007
- Decision Date: 03/20/2008
- Decision: Substantially Equivalent (SESE)
- Regulation Number: 872.42
- Product Code: EFB
- Subsequent Product Code: EGS
- Regulation Medical Specialty: Dental
- Review Panel: Dental
- Total Pages: 113 (48 unredacted, 57% redacted overall)
What's in this document (sections may appear in any order):
- ✗ 510(k) Summary / Statement: 76% redacted
- ~ Indications for Use: 51% redacted
- ✗ Device Description: 90% redacted
- ✗ Substantial Equivalence / Predicate: 74% redacted
- ~ Performance / Bench Testing: 50% redacted
- ✗ Biocompatibility: 62% redacted
- — Software / Cybersecurity: no distinct section found
- ✗ Sterilization / Shelf Life: 61% redacted
- ✗ Labeling / IFU: 78% redacted
- — Clinical Data: no distinct section found
- ✗ FDA Correspondence: 84% redacted
- — Risk Analysis / FMEA: no distinct section found
- ~ Electromagnetic Compatibility (EMC): 33% redacted
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
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