FDA.reportPublic FDA data

OVC3 Hybrid

Primary DI
09421031796815
Brand
OVC3 Hybrid
Company
RHONDIUM LIMITED
Model
OVC3 Hybrid Lower Molar Kit A2
Catalog number
9421031796815
Device description
The OVC3 Hybrid Lower Molar Kit A2 consists of a set of 6 OVCs in tooth shade A2 -one each for 2 tooth types, lower molar, in three sizes for each tooth type individually packaged. Each OVC3 Hybrid is packaged with 2 x OVC Wedges, 2 x Stretch Wedges, a Selector Key, 2 x OVC3 Matrix Band, and an OVC3 Hybrid Replica.
Published
2019-03-14
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
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143694000Rhondium One-Visit-Crown(OVC)Rhondium, Ltd.2015-05-15EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421031796815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421031796815094210317968159421031796815

GMDN Terms#

Term, Definition table
TermDefinition
Preformed dental crown, permanentA prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-875-6246info@rhondium.com

Regulatory Flags#

DUNS number
595078345
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421031793616OVC Hybrid OVC3 Hybrid FDI 14.15 XS : USA 4-5 XS A394210317936162017-09-15
09421031793623OVC Hybrid OVC3 Hybrid FDI 14.15 XS : USA 4-5 XS A294210317936232017-09-15
09421031793630OVC Hybrid OVC3 Hybrid FDI 14.15 S : USA 4-5 S A394210317936302017-09-15
09421031793647OVC Hybrid OVC3 Hybrid FDI 14.15 S : USA 4-5 S A294210317936472017-09-15
09421031793654OVC Hybrid OVC3 Hybrid FDI 14.15 M : USA 4-5 M A394210317936542017-09-15
09421031793661OVC Hybrid OVC3 Hybrid FDI 14.15 M : USA 4-5 M A294210317936612017-09-15
09421031793678OVC Hybrid OVC3 Hybrid FDI 14.15 L : USA 4-5 L A394210317936782017-09-15
09421031793685OVC Hybrid OVC3 Hybrid FDI 14.15 L : USA 4-5 L A294210317936852017-09-15
09421031793692OVC Hybrid OVC3 Hybrid FDI 14.15 XL : USA 4-5 XL A394210317936922017-09-15
09421031793708OVC Hybrid OVC3 Hybrid FDI 14.15 XL : USA 4-5 XL A294210317937082017-09-15
09421031793715OVC Hybrid OVC3 Hybrid FDI 16.17 XS : USA 2-3 XS A394210317937152017-09-15
09421031793722OVC Hybrid OVC3 Hybrid FDI 16.17 XS : USA 2-3 XS A294210317937222017-09-15
09421031793739OVC Hybrid OVC3 Hybrid FDI 16.17 S : USA 2-3 S A394210317937392017-09-15
09421031793746OVC Hybrid OVC3 Hybrid FDI 16.17 S : USA 2-3 S A294210317937462017-09-15
09421031793753OVC Hybrid OVC3 Hybrid FDI 16.17 M : USA 2-3 M A394210317937532017-09-15
09421031793760OVC Hybrid OVC3 Hybrid FDI 16.17 M : USA 2-3 M A294210317937602017-09-15
09421031793777OVC Hybrid OVC3 Hybrid FDI 16.17 L : USA 2-3 L A394210317937772017-09-15
09421031793784OVC Hybrid OVC3 Hybrid FDI 16.17 L : USA 2-3 L A294210317937842017-09-15
09421031793791OVC Hybrid OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A394210317937912017-09-15
09421031793807OVC Hybrid OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A294210317938072017-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
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