FDA.reportPublic FDA data

Waterlase Laser Tips

Primary DI
00647529001004
Brand
Waterlase Laser Tips
Company
BIOLASE, INC.
Model
MZ Zip Tip Combo
Catalog number
7200731
Device description
A tip kit containing 30 single-use MZ Zip tips intended for use with Waterlase laser delivery systems. The tips have the same length of 6 mm and core diameter of 500 and 600 microns.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647529001004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647529001004006475290010046475290010040647529001004

GMDN Terms#

Term, Definition table
TermDefinition
Dental solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter
Outer Diameter500Micrometer
Outer Diameter600Micrometer

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-321-6717Waterlaseservice@biolase.com

Regulatory Flags#

DUNS number
152165700
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00647529004722Waterlase iPlus Dental Laser SystemAll tissue YSGG dental laser system, red SG27200854-02W2025-01-31
00647529004777Waterlase iPlus Dental Laser SystemAll tissue YSGG dental laser system, platinum SG27200854-09W2025-01-31
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00647529003770Waterlase iPlus Dental Laser SystemFractional Handpiece Kit72200022023-08-01
00647529003787Waterlase iPlus Dental Laser SystemLaserFresh Accessory Kit Bundle72200052023-08-01
00647529000120Diode Laser Tipsperio, E3-9, single tip64003022023-06-19
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00647529000687Waterlase Laser Tips MZ6-4 62002222023-06-19
00647529000922Waterlase Laser Tips MZ6-1262002242023-06-19
00647529001509Waterlase Express Handpiece Handpiece, Single Unpacked72200012023-06-19
00647529001844Diode Laser Tipseztips, surgical assortment kit, 30PK64004802023-06-19
00647529001974Waterlase Laser Tips MZ10-9 Zip Tips62012022023-06-19
00647529002230Waterlase Laser TipsMZ8-9 ZipTips62011922023-06-19
00647529002674Waterlase MD Turbo Laser System7200401 Refurbished7200401P2023-06-19
00647529003008Waterlase Laser Tips C6-4, single60110812023-06-19
00647529003015Waterlase Laser Tips C6-6, single60110822023-06-19
00647529003282Waterlase MDX 450 Laser System 7200860-01P Certified Preowned2023-06-19
00647529003466Waterlase Express All-Tissue Laser SystemWaterlase Express laser refurbished7210001P2023-06-19
00647529003473Epic Pro Diode Laser SystemDental soft tissue diode laser system refurbished7410001P2023-06-19

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