FDA.report

NAC-03

Primary DI
04560264575349
Brand
NAC-03
Company
NAKANISHI INC.
Model
NAC-03
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications

CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560264575349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560264575349045602645753494560264575349

GMDN Terms

TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
690710546
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04589551389476Perio Kit APerio Kit A2026-02-13
04589551389483VA170VA1702026-02-13
04560264577763VA2-LUX-HP TiVA2-LUX-HP Ti2026-02-13
04589551387168Tip Cover LTip Cover L2026-01-21
04589551387151Tip Cover STip Cover S2026-01-21
04589551382828E TIP WRENCHE TIP WRENCH2026-01-21
04589551387144VariosCR-12026-01-21
04560264579958CLA-10CLA-102026-01-21
045895513889743 Mode Select Switch3 Mode Select Switch2026-01-21
04589551383863VariosG12022-12-13
04589551383870VariosG42022-12-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20686864060943MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
20686864060950MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
00850079280069Turbo EdgeHexa DentalEGS2026-01-21
00850079280083Turbo edgeHexa DentalEGS2026-01-21
00008579280083Turbo edgeHexa DentalEGS2026-01-21
00085007928069Turbo EdgeHexa DentalEGS2026-01-21
00850079280076Turbo EdgeHexa DentalEGS2026-01-21
00850079280090Turbo EdgeHexa DentalEGS2026-01-21
00850079280106Turbo EdgeHexa DentalEGS2026-01-21
00850079280113Ergo glideHexa DentalEGS2026-01-21
08404535020892Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020922Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020953Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020984Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535021738ForzaPeter Brasseler Holdings, LLCEGS2026-01-09
00304040194331Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194379Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
D745701120GLH00010Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00020Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00030Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D950135030SmoothdriveLARES RESEARCHEGS2025-08-25
06971119540548Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540586Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540593Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540982Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540999Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15