FDA.reportPublic FDA data

G-Stop Keys-Small-3mm

Primary DI
00850017652248
Brand
G-Stop Keys-Small-3mm
Company
VERSAH, LLC
Model
VTSP-S-O-3
Device description
Provides vertical control for drilling the osteotomy. The G-Stop Gauges and G-Stop Keys can be used with printed guides to control the angulation of the hole
Published
2020-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017652248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017652248008500176522488500176522480850017652248

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-711-5585info@versah.com

Regulatory Flags#

DUNS number
081472844
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
00850017652828Densah® Bur G3VT58682023-09-19
00810212140001VT1828-GSVT1828-GS2026-01-07
00810212140018VT2838-GSVT2838-GS2026-01-07
00810212140025VT3848-GSVT3848-GS2026-01-07
00810212140032VT4858-GSVT4858-GS2026-01-07
00810212140049VPLTT-GVPLTT-G2026-01-07
00810212140056VPLTT-GSVPLTT-GS2026-01-07
00810212140063VSINUSVSINUS2026-01-07
00850017652835Densah Bur HolderVBLK2026-01-07
00850017652842VT1525-GVT1525-G2026-01-07
00850017652859VT4555-GSVT4555-GS2026-01-07
00850017652866VT3545-GSVT3545-GS2026-01-07
00850017652873VT2535-GSVT2535-GS2026-01-07
00850017652880VT1525-GSVT1525-GS2026-01-07
00850017652897VT4858-GVT4858-G2026-01-07
00850017652903VT2535-GVT2535-G2026-01-07
00850017652910VT3545-GVT3545-G2026-01-07
00850017652927VT4555-GVT4555-G2026-01-07
00850017652934VT1828-GVT1828-G2026-01-07
00850017652941VT2838-GVT2838-G2026-01-07

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Primary DI, Brand, Company table
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08404535030006Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08404535030037Brasseler USA Sterile CarbidePeter Brasseler Holdings, LLCEJL2026-05-27
08435389830436EXTRA SHORT DRILL; Ø3.5 MMBIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830542FLATTENING FRONT CUTTING DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389830559FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
08435389831266FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0BIOTECHNOLOGY INSTITUTE SLEJL2026-05-27
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