FDA.reportPublic FDA data

Zuga

Primary DI
00854382006385
Brand
Zuga
Company
ZUGA MEDICAL, INC.
Model
RBT-001-002
Device description
Round Burr, 2.3mm
Published
2018-01-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122664000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122664000ZUGA DENTAL IMPLANT SYSTEMZuga Medical, Inc.2013-04-30DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854382006385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854382006385008543820063858543820063850854382006385

GMDN Terms#

Term, Definition table
TermDefinition
Pin/post dental drill bitA shaft of metal, typically with a spiralled portion at the cutting end (a twist drill bit), intended to be attached to a motorized handpiece, or other power source, to create a precise round hole at the appropriate depth in teeth or bone of the oral cavity. This hole or slot is used to secure cast or preformed pins/posts for stabilizing and retaining operative dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2162925910sales@zugamedical.com

Regulatory Flags#

DUNS number
055605664
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853095004923ZugaTRT-000-0002018-01-16
00854382006927ZugaTRT-000-0002018-01-16
00853095004893ZugaGST-350-0002018-01-15
00853095004909ZugaGST-430-0002018-01-16
00853095004916ZugaGST-500-0002018-01-16
00854382006897ZugaGST-350-0002018-01-12
00854382006903ZugaGST-430-0002018-01-12
00854382006910ZugaGST-500-0002018-01-12
00854382006408ZugaPGP-350-0002018-01-12
00854382006415ZugaPGP-430-0002018-01-12
00854382006422ZugaPGP-500-0002018-01-12
00853095004190ZugaTRK-350-0402018-01-12
00853095004206ZugaTRK-350-0552018-01-12
00853095004213ZugaTRK-430-0402018-01-12
00853095004220ZugaTRK-350-0702018-01-12
00853095004237ZugaTRK-430-0702018-01-12
00853095004244ZugaTRK-500-0702018-01-12
00853095004343ZugaTRK-430-0552018-01-12
00853095004350ZugaTRK-500-0402018-01-12
00853095004367ZugaTRK-500-0552018-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229002ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229019ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229026ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229033ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229040ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229057ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229064ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229071ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229088ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229095ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229101ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070229118ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-05
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04