FDA.reportPublic FDA data

Ultrasonic Scaler Tips

Primary DI
06973042242742
Brand
Ultrasonic Scaler Tips
Company
Guilin Veirun Medical Technology Co., Ltd.
Model
G8,5set/box
Device description
The trademark name is VRN
Published
2026-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZMNeedle, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZMNeedle, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973042242742PrimaryGS10
86973042242748Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973042242742069730422427426973042242742
8697304224274886973042242748

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
548206384
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06973042242674Ultrasonic Scaler TipsG1,5set/box2026-07-09
06973042242681Ultrasonic Scaler TipsG2,5set/box2026-07-09
06973042242698Ultrasonic Scaler TipsG3,5set/box2026-07-09
06973042242704Ultrasonic Scaler TipsG4,5set/box2026-07-09
06973042242711Ultrasonic Scaler TipsG5,5set/box2026-07-09
06973042242728Ultrasonic Scaler TipsG6,5set/box2026-07-09
06973042242735Ultrasonic Scaler TipsG7,5set/box2026-07-09
06973042242759Ultrasonic Scaler TipsG9,5set/box2026-07-09
06973042242766Ultrasonic Scaler TipsG12,5set/box2026-07-09
06973042242780Ultrasonic Scaler TipsS-G2,5set/box2026-07-09
06973042242797Ultrasonic Scaler TipsS-G3,5set/box2026-07-09
06973042242803Ultrasonic Scaler TipsS-G4,5set/box2026-07-09
06973042242810Ultrasonic Scaler TipsS-G5,5set/box2026-07-09
06973042242827Ultrasonic Scaler TipsS-G6,5set/box2026-07-09
06973042244265Ultrasonic Scaler TipsG1,5set/box2026-06-23
06973042242773Ultrasonic Scaler TipsS-G1,5set/box2026-06-24
06973042242858Ultrasonic Scaler TipsP1,5set/box2026-06-24
06973042244227Ultrasonic Scaler TipsS-P1,5set/box2026-06-23
06973042244234Ultrasonic Scaler TipsP3,5set/box2026-06-23
06973042244241Ultrasonic Scaler TipsP1,5set/box2026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973042242674Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242681Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242698Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242704Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242711Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242728Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242735Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242759Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242766Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242780Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242797Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242803Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242810Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
06973042242827Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-07-09
00841013124648MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.DZM2026-06-26
00841013124655MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.DZM2026-06-26
00841013124686MicroquoreAMERICAN EAGLE INSTRUMENTS, INC.DZM2026-06-26
06973042242773Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-24
06973042242858Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-24
06973042244227Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-23
06973042244234Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-23
06973042244241Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-23
06973042244258Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-23
06973042244265Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-23
06973042244272Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.DZM2026-06-23
D832BLT100501PlasdentPLASDENT CORPORATIONDZM2026-05-28
D1250802Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250812Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D1250822Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27
D125YS10012Premium PlusPremium Plus (Dongguan) LimitedDZM2026-05-27