FDA.reportPublic FDA data

POWERPRO

Primary DI
30845854028630
Brand
POWERPRO
Company
Conmed Corporation
Model
PRO6175
Catalog number
PRO6175
Device description
POWERPRO PNEUMATIC OSCILLATOR HANDPIECE
Published
2016-09-24
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
false

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
K032607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032607000POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185Linvatec Corp.2003-11-10DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854028630Direct MarkingGS10
10845854028636PrimaryGS10
20845854028633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585402863030845854028630
1084585402863610845854028636
2084585402863320845854028633

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, sawing, pneumaticA pneumatically-powered, hand-held device that consists of a motorized handpiece that provides sagittal, oscillating, or reciprocating movement for attachable serrated blades to cut through hard/tough tissue during surgery. The device may be of the micro or macro design and is typically powered by a compressed gas [e.g., surgical-grade air or nitrogen (N2)]. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
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
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
30845854655492PlumeSafe® X5™PX5-1354-22PX5-1354-222026-07-23
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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