FDA.report

Tatum Surgical-Tapered Osteotome Kit

Primary DI
00083208033339
Brand
Tatum Surgical-Tapered Osteotome Kit
Company
Suncoast Dental, Inc
Model
Tatum Tapered Straight Osteotome Kit
Catalog number
OsteotomeTapered Str 24
Device description
Tatum Tapered Straight Osteotome Kit designed for use in bone expansion utilizing Tatum Tapered & Integrity Implants: Includes 24 instruments and 2 Autoclaveable cassettes: White - 3.0x15, 18, 21, 23, Blue - 3.5x12, 15, 18, & 21 Red - 4.0x12, 15, 18, & 21 Yellow - 4.5x12, 15, 18, & 21 Black - 5.0x12, 15, 18, & 21 Green - 6.0x12, 15, 18, & 21
Published
2020-08-04
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
false

Related Records

Product Codes

CodeName
EMMChisel, Osteotome, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00083208033339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208033339000832080333390832080333390083208033339

GMDN Terms

TermDefinition
Dental osteotome setA collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
727-536-4880tatumcompliance@gmail.com

Regulatory Flags

DUNS number
078352849
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00083208503214Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 3 (CB) AbutmentIP-PN-5.0 x 3 (CB)2021-06-04
00083208504211Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 4 (CB) AbutmentIP-PN-5.0 x 4 (CB)2021-06-04
00083208505218Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 5 (CB) AbutmentIP-PN-5.0 x 5 (CB)2021-06-04
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00083208131004DDP Extraction Forceps Forceps (1-A)Forceps (1-A)2022-06-30
00083208131509DDP Extraction Forceps Forceps (150-A)Forceps (150-A)2022-06-30

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