FDA.reportPublic FDA data

Precise LTM Handpiece Collet

Primary DI
00872320002633
Brand
Precise LTM Handpiece Collet
Company
CAO GROUP, INC.
Model
00851
Device description
Replacement handpiece collet for use with the Precise LTM Diode Laser.
Published
2016-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062619000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062619000DENLASER 800 PLUSCAO Group, Inc.2006-11-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00872320003258PackageGS12In Commercial Distribution
00872320002633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320003258008723200032588723200032580872320003258
00872320002633008723200026338723200026330872320002633

GMDN Terms#

Term, Definition table
TermDefinition
Dental diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
877-236-4408info@caogroup.com

Regulatory Flags#

DUNS number
102422578
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

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00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mm051942026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, Straight052212026-04-10
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00872320006761Monet + Curing Laser001-001232026-02-10
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00872320003418Pilot Straight Tip006682016-11-10
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