FDA.reportPublic FDA data

Xtreme Power

Primary DI
D950133842360
Brand
Xtreme Power
Company
LARES RESEARCH
Model
XP5 Mini head signature grip, optic
Catalog number
13384-236
Device description
XP5 mini head high-speed dental handpiece, Signature grip, Optic
Published
2026-09-04
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141221000LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PRLares Research, Inc.2014-10-28EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D950133842360PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, pneumaticA pneumatically-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 a pneumatic motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5303451767bholderbein@laresdental.com

Regulatory Flags#

DUNS number
009127838
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
D950133802360Xtreme PowerXP Mini head signature grip, optic13380-2362026-09-04
D950133812360Xtreme PowerXP Mini head signature grip13381-2362026-09-04
D950133822360Xtreme PowerXP3 Mini head signature grip, optic13382-2362026-09-04
D950133832360Xtreme PowerXP3 Mini head signature grip13383-2362026-09-04
D950133852360Xtreme PowerXP5 Mini head signature grip13385-2362026-09-04
D950133902360Xtreme PowerXP Standard head signature grip, optic13390-2362026-09-04
D950133912360Xtreme PowerXP Standard head signature grip13391-2362026-09-04
D950133922360Xtreme PowerXP3 Standard head signature grip, optic13392-2362026-09-04
D950133932360Xtreme PowerXP3 Standard head signature grip13393-2362026-09-04
D950133942360Xtreme PowerXP5 Standard head signature grip, optic13394-2362026-09-04
D950133952360Xtreme PowerXP5 Standard head signature grip13395-2362026-09-04
D950134802360Xtreme PowerXP Mini head smooth grip, optic13480-2362026-09-04
D950134812360Xtreme PowerXP Mini head smooth grip13481-2362026-09-04
D950134822360Xtreme PowerXP3 Mini head smooth grip, optic13482-2362026-09-04
D950134832360Xtreme PowerXP3 Mini head smooth grip13483-2362026-09-04
D950134842360Xtreme PowerXP5 Mini head smooth grip, optic13484-2362026-09-04
D950134852360Xtreme PowerXP5 Mini head smooth grip13485-2362026-09-04
D950134902360Xtreme PowerXP Standard head smooth grip, optic13490-2362026-09-04
D950134912360Xtreme PowerXP Standard head smooth grip13491-2362026-09-04
D950134922360Xtreme PowerXP3 Standard head smooth grip, optic13492-2362026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
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