FDA.reportPublic FDA data

Universal Short Bur Adaptor - 5 Count

Primary DI
00840161301956
Brand
Universal Short Bur Adaptor - 5 Count
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z412
Device description
"Universal Short Bur Adaptor - Universal Short Bur Adaptor - 5 Count""Accommodates Zirc's 12 & 22 Hole Bur GuardsEnables long and short burs to be used in the same bur guard without the short burs falling outAutoclavable up to 136°C/275°FWasher-disinfect"""
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161301956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161301956008401613019568401613019560840161301956

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height12.7Millimeter
Length12.7Millimeter
Width11.1Millimeter

Regulatory Flags#

DUNS number
064783913
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840161312174Crystal HD® Mouth Mirrors50Z365N2026-10-12
00840161312181Crystal HD® Mouth Mirrors50Z385S2026-10-12
00840161312198Crystal HD® Mouth Mirrors50Z383-NEON2026-10-12
00840161311894Airway Armor® - Throat Guard - Large - 1 Count5Z960LG2026-05-01
00840161311900Airway Armor® - Throat Guard - Medium - 1 Count5Z960MD2026-05-01
00840161311917Airway Armor® - Throat Guard - Small - 1 Count5Z960SM2026-05-01
00840161307118Mr. Thirsty® One-Step - High Volume Evacuator - Large - 1 Count5Z989LG2026-04-30
00840161307132Mr. Thirsty® One-Step - High Volume Evacuator - Medium5Z989MD2026-04-30
00840161311887Mr. Thirsty® One-Step - High Volume Evacuator - Small5Z989SM2026-04-30
00840161311948Crystal HD® Mouth Mirrors50Z384SMPL2026-04-27
00840161311955Crystal HD® - Resin Mouth Mirror - #5 Soft Grip - 1 Count Sample Pack50Z364SMPL2026-04-27
10840161304794Airway Armor®50Z960SM2022-10-07
10840161304800Airway Armor®50Z960MD2022-10-07
10840161304817Airway Armor®50Z960LG2022-10-07
00840161304797Airway Armor® - Throat Guard - Small - 25 Count50Z960SM2026-04-07
00840161304803Airway Armor® - Throat Guard - Medium - 25 Count50Z960MD2026-04-07
00840161304810Airway Armor® - Throat Guard - Large - 25 Count50Z960LG2026-04-07
60840161307110Mr. Thirsty® One-Step - Large (with 10mm and 16mm Adaptors) - 50 Count50Z989LG10/162026-04-08
60840161307134Mr. Thirsty® One-Step - Medium (with 10mm and 16mm Adaptors) - 50 Count50Z989MD10/162026-04-08
60840161307158Mr. Thirsty® One-Step - Small (with 10mm and 16mm Adaptors) - 50 Count50Z989SM10/162026-04-08

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08800424704070GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704087Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
08800424704094Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
B382SD9233161140Surgical DirectSurgical Direct, Inc.FSM2026-11-03
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00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110133AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112182Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112199Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112205Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112250Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114025Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02