FDA.reportPublic FDA data

SURGYSTAR

Primary DI
08809462190005
Brand
SURGYSTAR
Company
Dmetec.Co., Ltd.
Model
G01
Published
2016-12-31
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
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113152000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113152000ULTRASONIC SURGERY MACHINEDmetec.Co., Ltd.2012-06-14DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809462190005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809462190005088094621900058809462190005

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment and cut bone upon contact with a vibrating tip during dental surgery, typically in combination with irrigation. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, and a foot-switch to regulate the energy. It is used for implant-site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty and osteotomy.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+827047167176ublee@dmetec.com

Regulatory Flags#

DUNS number
688451769
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809462190494COMPACT SS022018-03-19
08809462190500Cleanse S+S032017-07-07
08809462190029smarThorG032017-01-31
08809462190517SkyLightL012017-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652710PROstepSTRYKER CORPORATIONDZI2026-04-13
07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.DZI2026-04-08
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHDZI2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHDZI2023-10-12
J021079971101"Instrument Set ""Implant/Crestal P"""W & H Dentalwerk Bürmoos GmbHDZI2023-04-04
J021077856001Instrument Z25PW & H Dentalwerk Bürmoos GmbHDZI2023-04-04
J021303920001Handpiece SA-40 L with cable 1.8 mW & H Dentalwerk Bürmoos GmbHDZI2022-10-19
J021303920011Handpiece SA-40 L with cable 3.5 mW & H Dentalwerk Bürmoos GmbHDZI2022-10-19
J021303870001AMADEO M-UK1023W & H Dentalwerk Bürmoos GmbHDZI2022-08-23
J021300320031WS-75 LGW & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300530021S-9W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300560021S-11W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300590011S-10W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300600011S-15W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300610011S-12W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300650021WS-75W & H Dentalwerk Bürmoos GmbHDZI2022-06-23