FDA.reportPublic FDA data

G-Wedge™

Primary DI
00810038092928
Brand
G-Wedge™
Company
GARRISON DENTAL SOLUTIONS, L.L.C.
Model
GSWYL
Catalog number
GSWYL
Device description
Wedge Refill, X-Small, Yellow
Published
2020-04-24
Public version status
New
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
EJBHandle, Instrument, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810038092925PrimaryGS10
20810038092922PrimaryGS10
30810038092929PrimaryGS10
00810038092928Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003809292510810038092925
2081003809292220810038092922
3081003809292930810038092929
00810038092928008100380929288100380929280810038092928

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-437-0032gds@garrisondental.com

Regulatory Flags#

DUNS number
057647005
Device count
100
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
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
00810038091464LOOP™ LED Curing LightCLK01-RCLK01-R2025-02-27
00810038091471LOOP™ LED Curing LightCLK01-WCLK01-W2025-02-27
00810038091488LOOP™ LED Curing LightCLK01-SCLK01-S2025-02-27
00810038091129Quad Matrix System™QPLQPL2025-02-16
00810038091136Quad Matrix System™QK4-MQK4-M2025-02-16
00810038091143Quad Matrix System™QK4QK42025-02-16
00810038091150Quad Matrix System™QBLQBL2025-02-16
00810038091167Quad Matrix System™QORQOR2025-02-16
00810038091174Quad Matrix System™QGRQGR2025-02-16
00810038091181Quad Matrix System™QPL-MQPL-M2025-02-16
00810038091198Quad Matrix System™QBL-MQBL-M2025-02-16
00810038091204Quad Matrix System™QOR-MQOR-M2025-02-16
00810038091211Quad Matrix System™QGR-MQGR-M2025-02-16
00810038091228Quad Matrix System™QR01QR012025-02-16
00810038091235Quad Matrix System™Q400Q4002025-02-16
00810038091242Quad Matrix System™Q500Q5002025-02-16
00810038091259Quad Matrix System™Q400L-1Q400L-12025-02-16
00810038091266Quad Matrix System™Q400R-1Q400R-12025-02-16
00810038091273Quad Matrix System™Q500L-1Q500L-12025-02-16
00810038091280Quad Matrix System™Q500R-1Q500R-12025-02-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627759OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03