FDA.reportPublic FDA data

P300-2S120

Primary DI
04589551366361
Brand
P300-2S120
Company
NAKANISHI INC.
Model
P300-2S120
Published
2026-06-26
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

Product Codes#

Code, Name table
CodeName
ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202120000P300 AttachmentNakanishi, Inc.2021-10-22HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589551366460Direct MarkingGS10
04589551366361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589551366460045895513664604589551366460
04589551366361045895513663614589551366361

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551366217P300-2A100P300-2A1002026-06-26
04589551366262P300-2A120P300-2A1202026-06-26
04589551366316P300-2S100P300-2S1002026-06-26
04589551366422PD-IN-2-120PD-IN-2-1202026-06-26
04560264548459Powder Handpiece(For Prophy use)Powder Handpiece(For Prophy use)2026-06-11
04560264548473Powder Handpiece(For Perio use)Powder Handpiece(For Perio use)2026-06-11
04560264579538CLM Bottole SetCLM Bottle Set2026-06-11
04560264579569CLM HolderCLM Holder2026-06-11
04589551391202Prophy Kit2Prophy Kit22026-06-11
04589551391219Perio Kit2Perio Kit22026-06-11
04589551395095Varios Combi Pro2 Basic SetVarios Combi Pro2 Basic Set2026-06-11
04589551395323CLM Module SetCLM Module Set2026-06-11
04589551395347Water Bottle KitWater Bottle Kit2026-06-11
04589551395439FC-83FC-832026-06-11
04589551386758VA-SG-TIP HOLDERVA-SG-TIP HOLDER2026-04-08
04589551395088Multi Pad2Multi Pad22026-06-02
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22
04589551366613Sterile Cutting ToolUBS-RD50C2-072026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
10886982237217NASYNTHES (U.S.A.) LPHWE2019-02-21
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
10886982237613NASynthes GmbHHWE2017-02-20
10886982129512NASynthes GmbHHWE2016-12-31
10886982129598NASynthes GmbHHWE2016-12-31
10886982237729NASynthes GmbHHWE2016-12-31
10886982237989NASynthes GmbHHWE2016-12-31
10886982238795NASynthes GmbHHWE2016-12-31
10886982240323NASynthes GmbHHWE2016-12-31
10886982240347NASynthes GmbHHWE2016-12-31
10886982240361NASynthes GmbHHWE2016-12-31
10886982240385NASynthes GmbHHWE2016-12-31
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
10886982064721NASynthes GmbHHWE2016-06-30
10886982064721NASynthes GmbHERL2016-06-30
10886982064721NASynthes GmbHHBE2016-06-30
10886982064738NASynthes GmbHHWE2016-06-30
10886982064738NASynthes GmbHHBE2016-06-30