FDA.reportPublic FDA data

ZOLL-DENTAL

Primary DI
00840105210931
Brand
ZOLL-DENTAL
Company
Zoll-Dental
Model
PET-Z5
Device description
Tapper Z-5
Published
2021-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840105210931PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840105210931008401052109318401052109310840105210931

GMDN Terms#

Term, Definition table
TermDefinition
Periotome, reusableA hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(847)647-1819JEFF@ZOLLDENTAL.COM

Regulatory Flags#

DUNS number
005449822
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840105223856ZOLL DENTALBF-8X2026-08-18
00840105223009ZOLL DENTALSYR-4962-22023-07-11
00840105223818ZOLL DENTALZ-49342025-09-16
00840105223825ZOLL DENTALZ-49362025-09-16
00840105223832ZOLL DENTALZ-49372025-09-16
00840105223801ZOLL DENTALZ-49352025-08-11
00840105223757ZOLL DENTALGK-TUN-K62025-08-06
00840105223764ZOLL DENTALGK-TUN-K72025-08-06
00840105223771ZOLL DENTALGK-TUN-K82025-08-06
00840105223788ZOLL DENTALGK-TUN-K92025-08-06
00840105223795ZOLL DENTALGK-TUN-K102025-08-06
00840105223740ZOLL DENTALZ-99972025-07-24
00840105215226ZOLL-DENTALZ-10TKP2021-03-10
00840105215714ZOLL-DENTALZ-11TKP2021-03-10
00840105215967ZOLL-DENTALZ-12TKP2021-03-10
00840105216131ZOLL-DENTALZ-19-274-13-P2021-03-10
00840105216148ZOLL-DENTALZ-19-274-13-T2021-03-10
00840105216155ZOLL-DENTALZ-19-274-162021-03-10
00840105218388ZOLL-DENTALZ-44382021-03-10
00840105220268ZOLL-DENTALZ-71451-002021-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995267995Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268008Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268015Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268022Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268039Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00724995268046Snowden-PencerSTERIS Deutschland GmbHGEG2026-09-25
00190776431600MillenniumAvalign Technologies, Inc.GEG2026-09-22
00190776424091MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776428297MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776427733MillenniumAvalign Technologies, Inc.GEG2026-08-26
00190776427245MillenniumAvalign Technologies, Inc.GEG2026-08-21
00190776422646MillenniumAvalign Technologies, Inc.GEG2026-08-03
00190776422851MillenniumAvalign Technologies, Inc.GEG2026-08-03
B382SD350110Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD38060Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD4833125SN0Surgical DirectSurgical Direct, Inc.GEG2026-08-03
00190776422448MillenniumAvalign Technologies, Inc.GEG2026-07-31
00810143904598SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904604SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904611SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904628SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904642SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906264SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906325SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906370SURGIPROSSurgipros, LLCGEG2026-07-30
00810143907254SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934068SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934075SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934082SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934099SURGIPROSSurgipros, LLCGEG2026-07-30